Industry News
Measures for the Supervision and Administration of Inspection of Imported Medical Devices
2007-10-23 09:12:52
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Law of the People's Republic of China on Import and Export Commodity Inspection (hereinafter referred to as the Commodity Inspection Law) and its implementing regulations and other relevant laws and regulations in order to strengthen the inspection and supervision of imported medical devices and protect human health and life safety.
Article 2 These Measures apply to:
(i) Classification management of medical device import units;
(ii) Inspection and supervision of imported medical devices;
(iii) Risk warning and rapid response management of imported medical devices.
Article 3 The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the AQSIQ) is responsible for the inspection and supervision of imported medical devices nationwide, and is responsible for organizing the collection and collation of risk information and risk assessment related to imported medical devices, and taking risk warning and rapid response measures.
The entry-exit inspection and quarantine agencies of the AQSIQ (hereinafter referred to as the inspection and quarantine agencies) located in various places are responsible for the inspection and supervision of imported medical devices in their respective areas, and are responsible for collecting risk information related to imported medical devices and the specific implementation of rapid response measures.
Chapter II Classification Supervision of Medical Device Importers
Article 4 Inspection and quarantine agencies shall implement classification supervision on medical device importers based on their management level, integrity, risk level, quality status and import scale of imported medical device products, which are specifically divided into three categories.
Medical device importers may voluntarily apply for classification management according to the conditions.
Article 5 Category I import units shall meet the following conditions:
(i) Strictly abide by the Commodity Inspection Law and its implementing regulations, other relevant national laws and regulations, and relevant regulations of the General Administration of Quality Supervision, Inspection and Quarantine, have high integrity, and have no bad records for 5 consecutive years;
(ii) Have a sound quality management system, obtain ISO9000 quality system certification, and have a sound quality management system, including import inspection, incoming goods acceptance, warehousing and storage, quality tracking and defect reporting systems;
(iii) Have more than 2 quality management personnel who have been trained and qualified by the inspection and quarantine agency, are familiar with the basic technology, performance and structure of the relevant products, and understand my country's inspection and supervision of imported medical devices;
(iv) Agents or operators of imported medical devices that implement the compulsory product certification system shall obtain the corresponding certification documents;
(v) Agents or The imported medical devices it operates have a good reputation for quality, and no returns, claims or other accidents due to product quality liability have occurred within 2 years;
(VI) It has been engaged in the import business of medical devices for at least 6 years and can provide relevant certification documents;
(VII) It has imported at least 30 batches each year in the past 2 years;
(VIII) It has collected and preserved the national standards, industry standards and laws, regulations and special provisions on medical devices, established and preserved a relatively complete archive of imported medical devices, and the preservation period is not less than 10 years;
(IX) It has the technical training and after-sales service capabilities that are suitable for the medical devices it imports, or has agreed to provide technical support by a third party;
(X) It has relatively independent business premises and storage conditions that are suitable for the scope and scale of imported medical devices.
Article 6 Category II import units shall meet the following conditions:
(i) Strictly abide by the Commodity Inspection Law and its implementing regulations, other relevant national laws and regulations, and relevant regulations of the General Administration of Quality Supervision, Inspection and Quarantine, have a high degree of integrity, and have no bad records for three consecutive years;
(ii) Have a sound quality management system and a sound quality management system, including import inspection, incoming goods acceptance, warehousing and storage, quality tracking and defect reporting systems;
(iii) Have at least one quality management personnel who has been trained and qualified by the inspection and quarantine agency, who is familiar with the basic technology, performance and structure of the relevant products, and understands the inspection and supervision of imported medical devices in my country;
(iv) Agents or operators of imported medical devices that implement the compulsory product certification system shall obtain corresponding certification documents;
(v) Agents or operators The imported medical device products have a good reputation for quality, and no returns, claims or other accidents due to product quality responsibility have occurred within 1 year;
(VI) Engaged in the import business of medical devices for at least 3 years and can provide relevant certification documents;
(VII) Imported batches of at least 10 batches each year in the past 2 years;
(VIII) Collect and preserve national standards, industry standards and laws, regulations and special provisions on medical devices, establish and preserve relatively complete imported medical device data archives, and keep them for at least 10 years;
(IX) Have technical training and after-sales service capabilities that are suitable for the medical device products they import, or agree to provide technical support by a third party;
(X) Have a relatively independent business premises that are suitable for the scope and scale of imported medical device products.
Article 7 The three types of import units include:
(i) Import units that have been engaged in the import of medical devices for less than 3 years;
(ii) Import units that have been engaged in the import of medical devices for more than 3 years but have not applied for classification management;
(iii) Import units that have applied for classification but do not meet the conditions of Class I and Class II import units after assessment and are not included in Class I and Class II classification management.
Article 8 Medical device import units that apply for Class I or Class II import units (hereinafter referred to as applicants) shall apply to the local inspection and quarantine bureau and submit the following materials:
(i) Written application signed by the authorized person and sealed by the unit;
(ii) Legal person business license, medical device business license;
(iii) Quality management system certification, quality management documents;
(iv) Certification documents that quality management personnel have passed the training of inspection and quarantine institutions;
(v) Certification materials for annual import batches in the past two years;
(vi) A letter of commitment (self-declaration) to comply with relevant national laws and regulations and provide authenticity of information.
Article 9 The directly affiliated inspection and quarantine bureau shall complete the written review of the application submitted by the applicant within 5 working days. If the application materials are incomplete, the applicant shall be required to make corrections.
For applications for Class I import units, the directly affiliated inspection and quarantine bureau shall organize on-site assessment after completing the written review. If the assessment is qualified, the assessment results and relevant materials shall be reported to the General Administration of Quality Supervision, Inspection and Quarantine. The General Administration of Quality Supervision, Inspection and Quarantine shall approve the applicants who meet the conditions of Class I import units and publish the list of Class I import units on a regular basis.
For applications for Class II import units, after the directly affiliated inspection and quarantine bureau completes the written review, it may organize on-site assessment by itself or entrust the inspection and quarantine agency where the import unit is located. If the assessment is qualified, the directly affiliated inspection and quarantine bureau shall approve it and report it to the General Administration of Quality Supervision, Inspection and Quarantine for filing. The directly affiliated inspection and quarantine bureau is responsible for regularly publishing the list of Class II import units.
Chapter III Risk Level and Inspection and Supervision of Imported Medical Devices
Article 10 Inspection and quarantine agencies shall implement on-site inspection of imported medical devices and the inspection and supervision mode combined with subsequent supervision and management (hereinafter referred to as supervision inspection) in accordance with the risk level of imported medical devices and the classification of importing units in accordance with the relevant provisions of the General Administration of Quality Supervision, Inspection and Quarantine.
Article 11 The General Administration of Quality Supervision, Inspection and Quarantine shall classify imported medical devices into three risk levels: high risk, relatively high risk and general risk based on the structural characteristics, usage form, usage status, relevant rules of national medical device classification and the needs of import inspection and management of imported medical devices.
The risk level catalog of imported medical devices shall be determined and adjusted by the General Administration of Quality Supervision, Inspection and Quarantine and announced 60 days before the implementation date.
Article 12 Imported medical devices that meet the following conditions are classified as high-risk:
(i) Medical devices implanted in the human body;
(ii) Active medical devices that intervene in the human body;
(iii) Medical devices used to support and maintain life;
(iv) Medical imaging equipment and energy therapy equipment that are potentially dangerous to the human body;
(v) Medical devices with unstable product quality, multiple major quality accidents, and whose safety and effectiveness must be strictly controlled.
Article 13 Imported medical devices that meet the following conditions are classified as high-risk:
(i) Passive medical devices that intervene in the human body;
(ii) Other active medical devices that come into contact with the human body and are not classified as high-risk;
(iii) Medical devices with relatively unstable product quality, multiple quality problems, and whose safety and effectiveness must be strictly controlled.
Article 14 Imported medical devices that are not classified as high-risk or high-risk are classified as general-risk.
Article 15 For the import of high-risk medical devices, inspection management shall be carried out in the following manner:
(I) For import by Class I import units, a combination of on-site inspection and supervisory inspection shall be implemented, and the annual batch on-site inspection rate shall not be less than 50%;
(II) For import by Class II and Class III import units, batch on-site inspection shall be implemented.
Article 16 For the import of relatively high-risk medical devices, inspection management shall be carried out in the following manner:
(I) For import by Class I import units, the annual batch on-site inspection rate shall not be less than 30%;
(II) For import by Class II import units, the annual batch on-site inspection rate shall not be less than 50%;
(III) For import by Class III import units, batch on-site inspection shall be implemented.
Article 17 For the import of general risk medical devices, on-site inspection and supervisory inspection shall be combined for inspection management, and the annual batch on-site inspection rates are as follows:
(i) For imports by Class I import units, the annual batch on-site inspection rate shall not be less than 10%;
(ii) For imports by Class II import units, the annual batch on-site inspection rate shall not be less than 30%;
(iii) For imports by Class III import units, the annual batch on-site inspection rate shall not be less than 50%.
Article 18 As needed, the General Administration of Quality Supervision, Inspection and Quarantine may organize and implement supervision of manufacturing, pre-shipment inspection and loading supervision for high-risk imported medical devices in accordance with the foreign trade contract.
Article 19 When importing medical devices, the consignee or its agent (hereinafter referred to as the declarant) shall report to the inspection and quarantine agency at the place of declaration and provide the following materials:
(i) Documents required by the declaration regulations;
(ii) For medical devices included in the "Product Catalog for the Implementation of Compulsory Product Certification", the China Compulsory Certification Certificate shall be provided;
(iii) The registration certificate of imported medical devices approved and registered by the State Council's drug supervision and administration department;
(iv) If the importing unit is a Class I or Class II importing unit, the classification certificate of the importing unit issued by the inspection and quarantine agency shall be provided.
Article 20 The port inspection and quarantine agency shall review the inspection materials and notify the declarant if they do not meet the requirements; if they meet the requirements after review, the "Entry Goods Clearance Certificate" shall be issued. After the goods have completed the customs declaration procedures, they shall promptly apply to the inspection and quarantine agency for inspection.
Article 21 Imported medical devices shall be inspected at the destination declared by the declarant when reporting.
For imported medical devices that need to be inspected in conjunction with installation and commissioning, the place of use should be clearly stated when applying for inspection, and the inspection and quarantine agency at the place of use shall conduct the inspection. The catalog of imported medical devices that need to be inspected in conjunction with installation and commissioning shall be announced and implemented by the General Administration of Quality Supervision, Inspection and Quarantine.
For special products such as implantable medical devices, inspection shall be conducted at the inspection and quarantine agency designated by the General Administration of Quality Supervision, Inspection and Quarantine.
Article 22 Inspection and quarantine agencies shall inspect imported medical devices in accordance with the mandatory requirements of national technical specifications; if the mandatory requirements of national technical specifications have not yet been formulated, they may be inspected in accordance with the relevant foreign standards designated by the General Administration of Quality Supervision, Inspection and Quarantine.
Article 23 The content of on-site inspection and supervisory inspection of imported medical devices by inspection and quarantine agencies may include:
(i) Verification of consistency between products and relevant certificates;
(ii) Inspection of quantity, specifications, models and appearance;
(iii) Inspection of packaging, labels and signs. If wooden packaging is used, quarantine shall be implemented;
(iv) Verification of instructions and random documents;
(v) Inspection of mechanical, electrical, electromagnetic compatibility and other safety aspects;
(vi) Inspection of radiation, noise, biochemistry and other hygiene aspects;
(vii) Inspection of environmental protection aspects such as emission, residue and materials of toxic and hazardous substances;
(viii) Inspection of performance of medical devices involving diagnosis and treatment;
(ix) Verification of product identification, signs and Chinese instructions.
Article 24 Inspection and quarantine agencies shall implement entry verification for imported medical devices subject to the compulsory product certification system, check documents, verify whether the certificates and goods are consistent, and take samples to designated laboratories when necessary for testing in accordance with the compulsory product certification system and relevant standards stipulated by the state.
Article 25 If the imported medical devices are not found to be unqualified after inspection, the inspection and quarantine agency shall issue the "Incoming Goods Inspection and Quarantine Certificate".
If the inspection finds that they are unqualified, the inspection and quarantine agency shall issue the "Inspection and Quarantine Handling Notice", and if a claim is required, an inspection certificate shall be issued. If the items involving personal safety, health, and environmental protection are unqualified, or if the items that can be technically handled are still unqualified after technical handling, the inspection and quarantine agency shall order the parties to destroy them, or return them and inform the customs in writing, and report to the General Administration of Quality Supervision, Inspection and Quarantine.
Chapter IV Inspection and Supervision of Imported Donated Medical Devices
Article 26 Imported donated medical devices shall be unused and shall not carry items that are harmful to the environment, public health, or other prohibited items.
Article 27 Imported donated medical devices are prohibited from carrying items listed in my country's "Prohibited Import Goods Catalogue".
Article 28 Foreign donation institutions that donate medical devices to China must register the donation institutions and their donated medical devices with the General Administration of Quality Supervision, Inspection and Quarantine through their or their agents in China.
Article 29 The General Administration of Quality Supervision, Inspection and Quarantine may organize and implement pre-shipment inspection of imported donated medical devices when necessary.
Article 30 The unit or its agent that accepts imported donated medical devices shall submit relevant approval documents to the inspection and quarantine agency at the customs declaration place and apply for inspection to the inspection and quarantine agency at the place of use.
The inspection and quarantine agency shall accept the inspection with valid relevant approval documents, implement port inspection and inspection at the place of use.
Article 31 The recipient may use the donated medical devices after they have passed the inspection of the inspection and quarantine agency and issued the "Incoming Goods Inspection and Quarantine Certificate"; if they fail the inspection, they shall be handled in accordance with the relevant provisions of the Commodity Inspection Law and its implementing regulations.
Chapter V Risk Warning and Rapid Response
Article 32 The General Administration of Quality Supervision, Inspection and Quarantine shall establish a risk warning mechanism for imported medical devices. Through the collection and evaluation of information such as defective imported medical devices, warning information shall be issued in accordance with relevant regulations, and corresponding risk warning measures and rapid response measures shall be taken.
Article 33 Inspection and quarantine agencies shall regularly understand the quality status of imported medical devices used in their jurisdictions. If a major quality accident of imported medical devices is found, they shall promptly report to the General Administration of Quality Supervision, Inspection and Quarantine.
Article 34 Manufacturers, importers and users of imported medical devices shall report to the inspection and quarantine agencies if they find defects in their medical devices, and shall cooperate with the risk warning measures and rapid response measures taken by the inspection and quarantine agencies.
Article 35 Risk warning measures for defective imported medical devices include:
(i) Issue risk warning notices to inspection and quarantine agencies to strengthen inspection and supervision of medical devices produced by defective product manufacturers and imported by importers;
(ii) Issue risk warning notices to manufacturers and importers of defective products, urging them to take timely measures to eliminate defects.
Risks;
(III) Issue risk warning notices to consumers and users to remind them of the risks and hazards of defective imported medical devices;
(IV) Report the situation to relevant domestic departments, embassies or liaison offices of relevant countries and regions in China, and relevant international organizations and institutions, and recommend them to take necessary measures.
Article 36 Rapid response measures to defective imported medical devices include:
(I) Recommend suspension of use of defective medical devices;
(II) Adjust the classification management of import units of defective imported medical devices;
(III) Stop importing defective medical devices;
(IV) Suspend or revoke the national compulsory product certification certificate of defective imported medical devices;
(V) Other necessary measures.
Chapter VI Supervision and Management
Article 37 The inspection and quarantine agency shall conduct at least one supervision and audit of Class I and Class II import units each year. If any of the following circumstances are found, the import unit may be downgraded according to the severity of the circumstances:
(I) The import unit has a bad credit record;
(II) The imported medical devices have major safety hazards or major quality problems;
(III) After inspection by the inspection and quarantine agency, the import unit has 10% of unqualified batches in the annual import batches;
(IV) The import unit's annual import batches do not meet the requirements;
(V) The import unit has other violations of laws and regulations.
The downgraded import unit must apply to restore the original classification management category after 12 months, and must be re-assessed, approved and announced.
Article 38 If any of the following situations occur in imported medical devices, the inspection and quarantine agency may, with the approval of the head of the agency, seal or detain the imported medical devices, except for goods under customs supervision:
(i) Those prohibited from import;
(ii) Those with safety and health defects or that may cause health hazards or environmental pollution;
(iii) Those that may endanger the life and property of patients and are in an emergency.
Article 39 The General Administration of Quality Supervision, Inspection and Quarantine is responsible for the training and assessment of the qualifications of the inspection and supervision personnel of imported medical devices in the inspection and quarantine agencies. Personnel who have not passed the assessment shall not engage in the inspection and supervision of imported medical devices.
Article 40 Used imported medical devices used for scientific research and other purposes other than for patients may be imported only after approval by the General Administration of Quality Supervision, Inspection and Quarantine and other relevant departments.
Imported medical devices remanufactured by the original factory, whose safety and technical performance meet the requirements of new medical devices and comply with other relevant national regulations, may be imported only after the inspection and quarantine agency conducts a conformity assessment and approval by the General Administration of Quality Supervision, Inspection and Quarantine.
It is prohibited to import other used medical devices other than those specified in the first two paragraphs.
Chapter VII Legal Liability
Article 41 Anyone who sells or uses imported medical devices that are subject to statutory inspection without reporting for inspection or inspection, or anyone who sells or uses imported medical devices that should apply for import verification but fail to apply for it, shall have his illegal gains confiscated by the inspection and quarantine agency, and be fined not less than 5% but not more than 20% of the value of the goods; if a crime is constituted, criminal liability shall be investigated according to law.
Article 42 Anyone who sells or uses imported medical devices that fail statutory inspection, random inspection or verification shall be ordered by the inspection and quarantine agency to stop selling or using them, confiscate the illegal gains and the goods illegally sold or used, and be fined not less than 3 times the value of the goods illegally sold or used; if a crime is constituted, criminal liability shall be investigated according to law.
Article 43 If an importer of medical devices imports used medical devices that are prohibited from import by the state, they shall be returned or destroyed in accordance with relevant national regulations. If the imported used medical devices are electromechanical products, the inspection and quarantine agency shall impose a fine of not more than RMB 1 million if the circumstances are serious.
Article 44 If the staff of the inspection and quarantine agency abuses their power, deliberately makes things difficult, commits malpractice for personal gain, falsifies inspection results, or neglects their duties and delays the inspection and certification, they shall be given administrative sanctions according to law; if a crime is constituted, they shall be investigated for criminal responsibility according to law.
Chapter VIII Supplementary Provisions
Article 45 The imported medical devices referred to in these Measures refer to instruments, equipment, appliances, materials or other items that enter the territory of the People's Republic of China from abroad and are used on the human body alone or in combination, including the software used in conjunction with them, and their use is intended to prevent, diagnose, treat, monitor, and alleviate diseases, diagnose, treat, monitor, alleviate, and compensate for injuries or disabilities, study, replace, and regulate anatomical or physiological processes, and control pregnancy.
The defective imported medical devices referred to in these Measures refer to imported medical devices that do not meet the provisions of national mandatory standards or have unreasonable risks that may endanger the safety of people and property.
The importing unit referred to in these Measures refers to a Chinese enterprise with legal person status that signs and executes import medical device trade contracts or entrusts foreign trade agents to import medical devices.
Article 46 Medical devices entering customs-controlled areas such as bonded areas and export processing zones from abroad for use, as well as medical devices entering other areas within the country from customs-controlled areas such as bonded areas and export processing zones, shall be subject to these Measures.
Article 47 Imported medical devices for animals shall be subject to these Measures.
Article 48 For imported medical devices that are boiler pressure vessels, their safety supervision inspection shall also comply with other relevant regulations of the General Administration of Quality Supervision, Inspection and Quarantine. Imported medical devices that are included in the "Catalogue of Type Examination of Imported Measuring Instruments of the People's Republic of China" shall also comply with the provisions of relevant national metrology laws and regulations.
Article 49 The General Administration of Quality Supervision, Inspection and Quarantine shall be responsible for interpreting these Measures.
Article 50 These Measures shall come into force on December 1, 2007.
Article 1 These Measures are formulated in accordance with the Law of the People's Republic of China on Import and Export Commodity Inspection (hereinafter referred to as the Commodity Inspection Law) and its implementing regulations and other relevant laws and regulations in order to strengthen the inspection and supervision of imported medical devices and protect human health and life safety.
Article 2 These Measures apply to:
(i) Classification management of medical device import units;
(ii) Inspection and supervision of imported medical devices;
(iii) Risk warning and rapid response management of imported medical devices.
Article 3 The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the AQSIQ) is responsible for the inspection and supervision of imported medical devices nationwide, and is responsible for organizing the collection and collation of risk information and risk assessment related to imported medical devices, and taking risk warning and rapid response measures.
The entry-exit inspection and quarantine agencies of the AQSIQ (hereinafter referred to as the inspection and quarantine agencies) located in various places are responsible for the inspection and supervision of imported medical devices in their respective areas, and are responsible for collecting risk information related to imported medical devices and the specific implementation of rapid response measures.
Chapter II Classification Supervision of Medical Device Importers
Article 4 Inspection and quarantine agencies shall implement classification supervision on medical device importers based on their management level, integrity, risk level, quality status and import scale of imported medical device products, which are specifically divided into three categories.
Medical device importers may voluntarily apply for classification management according to the conditions.
Article 5 Category I import units shall meet the following conditions:
(i) Strictly abide by the Commodity Inspection Law and its implementing regulations, other relevant national laws and regulations, and relevant regulations of the General Administration of Quality Supervision, Inspection and Quarantine, have high integrity, and have no bad records for 5 consecutive years;
(ii) Have a sound quality management system, obtain ISO9000 quality system certification, and have a sound quality management system, including import inspection, incoming goods acceptance, warehousing and storage, quality tracking and defect reporting systems;
(iii) Have more than 2 quality management personnel who have been trained and qualified by the inspection and quarantine agency, are familiar with the basic technology, performance and structure of the relevant products, and understand my country's inspection and supervision of imported medical devices;
(iv) Agents or operators of imported medical devices that implement the compulsory product certification system shall obtain the corresponding certification documents;
(v) Agents or The imported medical devices it operates have a good reputation for quality, and no returns, claims or other accidents due to product quality liability have occurred within 2 years;
(VI) It has been engaged in the import business of medical devices for at least 6 years and can provide relevant certification documents;
(VII) It has imported at least 30 batches each year in the past 2 years;
(VIII) It has collected and preserved the national standards, industry standards and laws, regulations and special provisions on medical devices, established and preserved a relatively complete archive of imported medical devices, and the preservation period is not less than 10 years;
(IX) It has the technical training and after-sales service capabilities that are suitable for the medical devices it imports, or has agreed to provide technical support by a third party;
(X) It has relatively independent business premises and storage conditions that are suitable for the scope and scale of imported medical devices.
Article 6 Category II import units shall meet the following conditions:
(i) Strictly abide by the Commodity Inspection Law and its implementing regulations, other relevant national laws and regulations, and relevant regulations of the General Administration of Quality Supervision, Inspection and Quarantine, have a high degree of integrity, and have no bad records for three consecutive years;
(ii) Have a sound quality management system and a sound quality management system, including import inspection, incoming goods acceptance, warehousing and storage, quality tracking and defect reporting systems;
(iii) Have at least one quality management personnel who has been trained and qualified by the inspection and quarantine agency, who is familiar with the basic technology, performance and structure of the relevant products, and understands the inspection and supervision of imported medical devices in my country;
(iv) Agents or operators of imported medical devices that implement the compulsory product certification system shall obtain corresponding certification documents;
(v) Agents or operators The imported medical device products have a good reputation for quality, and no returns, claims or other accidents due to product quality responsibility have occurred within 1 year;
(VI) Engaged in the import business of medical devices for at least 3 years and can provide relevant certification documents;
(VII) Imported batches of at least 10 batches each year in the past 2 years;
(VIII) Collect and preserve national standards, industry standards and laws, regulations and special provisions on medical devices, establish and preserve relatively complete imported medical device data archives, and keep them for at least 10 years;
(IX) Have technical training and after-sales service capabilities that are suitable for the medical device products they import, or agree to provide technical support by a third party;
(X) Have a relatively independent business premises that are suitable for the scope and scale of imported medical device products.
Article 7 The three types of import units include:
(i) Import units that have been engaged in the import of medical devices for less than 3 years;
(ii) Import units that have been engaged in the import of medical devices for more than 3 years but have not applied for classification management;
(iii) Import units that have applied for classification but do not meet the conditions of Class I and Class II import units after assessment and are not included in Class I and Class II classification management.
Article 8 Medical device import units that apply for Class I or Class II import units (hereinafter referred to as applicants) shall apply to the local inspection and quarantine bureau and submit the following materials:
(i) Written application signed by the authorized person and sealed by the unit;
(ii) Legal person business license, medical device business license;
(iii) Quality management system certification, quality management documents;
(iv) Certification documents that quality management personnel have passed the training of inspection and quarantine institutions;
(v) Certification materials for annual import batches in the past two years;
(vi) A letter of commitment (self-declaration) to comply with relevant national laws and regulations and provide authenticity of information.
Article 9 The directly affiliated inspection and quarantine bureau shall complete the written review of the application submitted by the applicant within 5 working days. If the application materials are incomplete, the applicant shall be required to make corrections.
For applications for Class I import units, the directly affiliated inspection and quarantine bureau shall organize on-site assessment after completing the written review. If the assessment is qualified, the assessment results and relevant materials shall be reported to the General Administration of Quality Supervision, Inspection and Quarantine. The General Administration of Quality Supervision, Inspection and Quarantine shall approve the applicants who meet the conditions of Class I import units and publish the list of Class I import units on a regular basis.
For applications for Class II import units, after the directly affiliated inspection and quarantine bureau completes the written review, it may organize on-site assessment by itself or entrust the inspection and quarantine agency where the import unit is located. If the assessment is qualified, the directly affiliated inspection and quarantine bureau shall approve it and report it to the General Administration of Quality Supervision, Inspection and Quarantine for filing. The directly affiliated inspection and quarantine bureau is responsible for regularly publishing the list of Class II import units.
Chapter III Risk Level and Inspection and Supervision of Imported Medical Devices
Article 10 Inspection and quarantine agencies shall implement on-site inspection of imported medical devices and the inspection and supervision mode combined with subsequent supervision and management (hereinafter referred to as supervision inspection) in accordance with the risk level of imported medical devices and the classification of importing units in accordance with the relevant provisions of the General Administration of Quality Supervision, Inspection and Quarantine.
Article 11 The General Administration of Quality Supervision, Inspection and Quarantine shall classify imported medical devices into three risk levels: high risk, relatively high risk and general risk based on the structural characteristics, usage form, usage status, relevant rules of national medical device classification and the needs of import inspection and management of imported medical devices.
The risk level catalog of imported medical devices shall be determined and adjusted by the General Administration of Quality Supervision, Inspection and Quarantine and announced 60 days before the implementation date.
Article 12 Imported medical devices that meet the following conditions are classified as high-risk:
(i) Medical devices implanted in the human body;
(ii) Active medical devices that intervene in the human body;
(iii) Medical devices used to support and maintain life;
(iv) Medical imaging equipment and energy therapy equipment that are potentially dangerous to the human body;
(v) Medical devices with unstable product quality, multiple major quality accidents, and whose safety and effectiveness must be strictly controlled.
Article 13 Imported medical devices that meet the following conditions are classified as high-risk:
(i) Passive medical devices that intervene in the human body;
(ii) Other active medical devices that come into contact with the human body and are not classified as high-risk;
(iii) Medical devices with relatively unstable product quality, multiple quality problems, and whose safety and effectiveness must be strictly controlled.
Article 14 Imported medical devices that are not classified as high-risk or high-risk are classified as general-risk.
Article 15 For the import of high-risk medical devices, inspection management shall be carried out in the following manner:
(I) For import by Class I import units, a combination of on-site inspection and supervisory inspection shall be implemented, and the annual batch on-site inspection rate shall not be less than 50%;
(II) For import by Class II and Class III import units, batch on-site inspection shall be implemented.
Article 16 For the import of relatively high-risk medical devices, inspection management shall be carried out in the following manner:
(I) For import by Class I import units, the annual batch on-site inspection rate shall not be less than 30%;
(II) For import by Class II import units, the annual batch on-site inspection rate shall not be less than 50%;
(III) For import by Class III import units, batch on-site inspection shall be implemented.
Article 17 For the import of general risk medical devices, on-site inspection and supervisory inspection shall be combined for inspection management, and the annual batch on-site inspection rates are as follows:
(i) For imports by Class I import units, the annual batch on-site inspection rate shall not be less than 10%;
(ii) For imports by Class II import units, the annual batch on-site inspection rate shall not be less than 30%;
(iii) For imports by Class III import units, the annual batch on-site inspection rate shall not be less than 50%.
Article 18 As needed, the General Administration of Quality Supervision, Inspection and Quarantine may organize and implement supervision of manufacturing, pre-shipment inspection and loading supervision for high-risk imported medical devices in accordance with the foreign trade contract.
Article 19 When importing medical devices, the consignee or its agent (hereinafter referred to as the declarant) shall report to the inspection and quarantine agency at the place of declaration and provide the following materials:
(i) Documents required by the declaration regulations;
(ii) For medical devices included in the "Product Catalog for the Implementation of Compulsory Product Certification", the China Compulsory Certification Certificate shall be provided;
(iii) The registration certificate of imported medical devices approved and registered by the State Council's drug supervision and administration department;
(iv) If the importing unit is a Class I or Class II importing unit, the classification certificate of the importing unit issued by the inspection and quarantine agency shall be provided.
Article 20 The port inspection and quarantine agency shall review the inspection materials and notify the declarant if they do not meet the requirements; if they meet the requirements after review, the "Entry Goods Clearance Certificate" shall be issued. After the goods have completed the customs declaration procedures, they shall promptly apply to the inspection and quarantine agency for inspection.
Article 21 Imported medical devices shall be inspected at the destination declared by the declarant when reporting.
For imported medical devices that need to be inspected in conjunction with installation and commissioning, the place of use should be clearly stated when applying for inspection, and the inspection and quarantine agency at the place of use shall conduct the inspection. The catalog of imported medical devices that need to be inspected in conjunction with installation and commissioning shall be announced and implemented by the General Administration of Quality Supervision, Inspection and Quarantine.
For special products such as implantable medical devices, inspection shall be conducted at the inspection and quarantine agency designated by the General Administration of Quality Supervision, Inspection and Quarantine.
Article 22 Inspection and quarantine agencies shall inspect imported medical devices in accordance with the mandatory requirements of national technical specifications; if the mandatory requirements of national technical specifications have not yet been formulated, they may be inspected in accordance with the relevant foreign standards designated by the General Administration of Quality Supervision, Inspection and Quarantine.
Article 23 The content of on-site inspection and supervisory inspection of imported medical devices by inspection and quarantine agencies may include:
(i) Verification of consistency between products and relevant certificates;
(ii) Inspection of quantity, specifications, models and appearance;
(iii) Inspection of packaging, labels and signs. If wooden packaging is used, quarantine shall be implemented;
(iv) Verification of instructions and random documents;
(v) Inspection of mechanical, electrical, electromagnetic compatibility and other safety aspects;
(vi) Inspection of radiation, noise, biochemistry and other hygiene aspects;
(vii) Inspection of environmental protection aspects such as emission, residue and materials of toxic and hazardous substances;
(viii) Inspection of performance of medical devices involving diagnosis and treatment;
(ix) Verification of product identification, signs and Chinese instructions.
Article 24 Inspection and quarantine agencies shall implement entry verification for imported medical devices subject to the compulsory product certification system, check documents, verify whether the certificates and goods are consistent, and take samples to designated laboratories when necessary for testing in accordance with the compulsory product certification system and relevant standards stipulated by the state.
Article 25 If the imported medical devices are not found to be unqualified after inspection, the inspection and quarantine agency shall issue the "Incoming Goods Inspection and Quarantine Certificate".
If the inspection finds that they are unqualified, the inspection and quarantine agency shall issue the "Inspection and Quarantine Handling Notice", and if a claim is required, an inspection certificate shall be issued. If the items involving personal safety, health, and environmental protection are unqualified, or if the items that can be technically handled are still unqualified after technical handling, the inspection and quarantine agency shall order the parties to destroy them, or return them and inform the customs in writing, and report to the General Administration of Quality Supervision, Inspection and Quarantine.
Chapter IV Inspection and Supervision of Imported Donated Medical Devices
Article 26 Imported donated medical devices shall be unused and shall not carry items that are harmful to the environment, public health, or other prohibited items.
Article 27 Imported donated medical devices are prohibited from carrying items listed in my country's "Prohibited Import Goods Catalogue".
Article 28 Foreign donation institutions that donate medical devices to China must register the donation institutions and their donated medical devices with the General Administration of Quality Supervision, Inspection and Quarantine through their or their agents in China.
Article 29 The General Administration of Quality Supervision, Inspection and Quarantine may organize and implement pre-shipment inspection of imported donated medical devices when necessary.
Article 30 The unit or its agent that accepts imported donated medical devices shall submit relevant approval documents to the inspection and quarantine agency at the customs declaration place and apply for inspection to the inspection and quarantine agency at the place of use.
The inspection and quarantine agency shall accept the inspection with valid relevant approval documents, implement port inspection and inspection at the place of use.
Article 31 The recipient may use the donated medical devices after they have passed the inspection of the inspection and quarantine agency and issued the "Incoming Goods Inspection and Quarantine Certificate"; if they fail the inspection, they shall be handled in accordance with the relevant provisions of the Commodity Inspection Law and its implementing regulations.
Chapter V Risk Warning and Rapid Response
Article 32 The General Administration of Quality Supervision, Inspection and Quarantine shall establish a risk warning mechanism for imported medical devices. Through the collection and evaluation of information such as defective imported medical devices, warning information shall be issued in accordance with relevant regulations, and corresponding risk warning measures and rapid response measures shall be taken.
Article 33 Inspection and quarantine agencies shall regularly understand the quality status of imported medical devices used in their jurisdictions. If a major quality accident of imported medical devices is found, they shall promptly report to the General Administration of Quality Supervision, Inspection and Quarantine.
Article 34 Manufacturers, importers and users of imported medical devices shall report to the inspection and quarantine agencies if they find defects in their medical devices, and shall cooperate with the risk warning measures and rapid response measures taken by the inspection and quarantine agencies.
Article 35 Risk warning measures for defective imported medical devices include:
(i) Issue risk warning notices to inspection and quarantine agencies to strengthen inspection and supervision of medical devices produced by defective product manufacturers and imported by importers;
(ii) Issue risk warning notices to manufacturers and importers of defective products, urging them to take timely measures to eliminate defects.
Risks;
(III) Issue risk warning notices to consumers and users to remind them of the risks and hazards of defective imported medical devices;
(IV) Report the situation to relevant domestic departments, embassies or liaison offices of relevant countries and regions in China, and relevant international organizations and institutions, and recommend them to take necessary measures.
Article 36 Rapid response measures to defective imported medical devices include:
(I) Recommend suspension of use of defective medical devices;
(II) Adjust the classification management of import units of defective imported medical devices;
(III) Stop importing defective medical devices;
(IV) Suspend or revoke the national compulsory product certification certificate of defective imported medical devices;
(V) Other necessary measures.
Chapter VI Supervision and Management
Article 37 The inspection and quarantine agency shall conduct at least one supervision and audit of Class I and Class II import units each year. If any of the following circumstances are found, the import unit may be downgraded according to the severity of the circumstances:
(I) The import unit has a bad credit record;
(II) The imported medical devices have major safety hazards or major quality problems;
(III) After inspection by the inspection and quarantine agency, the import unit has 10% of unqualified batches in the annual import batches;
(IV) The import unit's annual import batches do not meet the requirements;
(V) The import unit has other violations of laws and regulations.
The downgraded import unit must apply to restore the original classification management category after 12 months, and must be re-assessed, approved and announced.
Article 38 If any of the following situations occur in imported medical devices, the inspection and quarantine agency may, with the approval of the head of the agency, seal or detain the imported medical devices, except for goods under customs supervision:
(i) Those prohibited from import;
(ii) Those with safety and health defects or that may cause health hazards or environmental pollution;
(iii) Those that may endanger the life and property of patients and are in an emergency.
Article 39 The General Administration of Quality Supervision, Inspection and Quarantine is responsible for the training and assessment of the qualifications of the inspection and supervision personnel of imported medical devices in the inspection and quarantine agencies. Personnel who have not passed the assessment shall not engage in the inspection and supervision of imported medical devices.
Article 40 Used imported medical devices used for scientific research and other purposes other than for patients may be imported only after approval by the General Administration of Quality Supervision, Inspection and Quarantine and other relevant departments.
Imported medical devices remanufactured by the original factory, whose safety and technical performance meet the requirements of new medical devices and comply with other relevant national regulations, may be imported only after the inspection and quarantine agency conducts a conformity assessment and approval by the General Administration of Quality Supervision, Inspection and Quarantine.
It is prohibited to import other used medical devices other than those specified in the first two paragraphs.
Chapter VII Legal Liability
Article 41 Anyone who sells or uses imported medical devices that are subject to statutory inspection without reporting for inspection or inspection, or anyone who sells or uses imported medical devices that should apply for import verification but fail to apply for it, shall have his illegal gains confiscated by the inspection and quarantine agency, and be fined not less than 5% but not more than 20% of the value of the goods; if a crime is constituted, criminal liability shall be investigated according to law.
Article 42 Anyone who sells or uses imported medical devices that fail statutory inspection, random inspection or verification shall be ordered by the inspection and quarantine agency to stop selling or using them, confiscate the illegal gains and the goods illegally sold or used, and be fined not less than 3 times the value of the goods illegally sold or used; if a crime is constituted, criminal liability shall be investigated according to law.
Article 43 If an importer of medical devices imports used medical devices that are prohibited from import by the state, they shall be returned or destroyed in accordance with relevant national regulations. If the imported used medical devices are electromechanical products, the inspection and quarantine agency shall impose a fine of not more than RMB 1 million if the circumstances are serious.
Article 44 If the staff of the inspection and quarantine agency abuses their power, deliberately makes things difficult, commits malpractice for personal gain, falsifies inspection results, or neglects their duties and delays the inspection and certification, they shall be given administrative sanctions according to law; if a crime is constituted, they shall be investigated for criminal responsibility according to law.
Chapter VIII Supplementary Provisions
Article 45 The imported medical devices referred to in these Measures refer to instruments, equipment, appliances, materials or other items that enter the territory of the People's Republic of China from abroad and are used on the human body alone or in combination, including the software used in conjunction with them, and their use is intended to prevent, diagnose, treat, monitor, and alleviate diseases, diagnose, treat, monitor, alleviate, and compensate for injuries or disabilities, study, replace, and regulate anatomical or physiological processes, and control pregnancy.
The defective imported medical devices referred to in these Measures refer to imported medical devices that do not meet the provisions of national mandatory standards or have unreasonable risks that may endanger the safety of people and property.
The importing unit referred to in these Measures refers to a Chinese enterprise with legal person status that signs and executes import medical device trade contracts or entrusts foreign trade agents to import medical devices.
Article 46 Medical devices entering customs-controlled areas such as bonded areas and export processing zones from abroad for use, as well as medical devices entering other areas within the country from customs-controlled areas such as bonded areas and export processing zones, shall be subject to these Measures.
Article 47 Imported medical devices for animals shall be subject to these Measures.
Article 48 For imported medical devices that are boiler pressure vessels, their safety supervision inspection shall also comply with other relevant regulations of the General Administration of Quality Supervision, Inspection and Quarantine. Imported medical devices that are included in the "Catalogue of Type Examination of Imported Measuring Instruments of the People's Republic of China" shall also comply with the provisions of relevant national metrology laws and regulations.
Article 49 The General Administration of Quality Supervision, Inspection and Quarantine shall be responsible for interpreting these Measures.
Article 50 These Measures shall come into force on December 1, 2007.
