Soliciting opinions on the "Measures for the Management of Quality Spot Checks and Inspections of Medical Devices"

Medical NetworkAugust 28th: On August 27th, to further strengthen the quality inspection and testing management of medical devices and improve the procedures and requirements for medical device sampling inspections, the National Medical Products Administration (NMPA) revised the current "Regulations on the Supervision and Inspection of Medical Device Quality" (Food and Drug Administration Medical Device Supervision [2013] No. 212), forming the "Measures for the Quality Inspection and Testing of Medical Devices (Draft for Comments)", which is now open for public comment.

 

　　The original text is as follows:

 

　　Measures for the Quality Inspection and Testing of Medical Devices

 

　　 (Draft for Comments)

 

　　Chapter 1 General Provisions

 

　　Article 1 [Purpose] To strengthen the supervision and management of medical device quality and standardize the quality inspection and testing of medical devices, these measures are formulated in accordance with the provisions of the "Regulations on the Supervision and Management of Medical Devices".

 

　　Article 2 [Scope of Application] These measures apply to the quality inspection and testing of medical devices carried out within the territory of the People's Republic of China by drug supervision and management departments.

 

　　Article 3 [Responsibilities of Regulatory Departments] The National Medical Products Administration is responsible for organizing and implementing national medical device quality inspection and testing.

 

　　Provincial drug supervision and management departments are responsible for conducting sampling inspections of medical devices produced and sold through internet sales platforms in their administrative regions. They organize the departments responsible for drug supervision and management of municipal and county-level people's governments to conduct sampling inspections of medical devices in the circulation and use stages within their administrative regions and undertake medical device quality sampling inspection tasks assigned by higher-level drug supervision and management departments.

 

　　Higher-level drug supervision and management departments guide and supervise lower-level drug supervision and management departments in carrying out medical device quality inspection and testing.

 

　　Article 4 [Responsibilities of Testing Institutions] The China National Institute for Food and Drug Control is responsible for formulating plans and programs for national medical device quality sampling inspections and providing technical guidance.

 

　　Medical device testing institutions with relevant testing qualifications undertake medical device quality sampling inspection tasks.

 

　　Article 5 [Obligations of Enterprises] Units and relevant personnel engaged in the production, operation, and use of medical devices shall accept the medical device quality sampling inspection organized and implemented by the drug supervision and management departments in accordance with these measures. They shall not interfere with, obstruct, or refuse sampling inspection work, transfer or conceal medical devices, or refuse to provide supporting materials or intentionally provide false information.

 

　　For products found to be non-compliant through sampling inspection, units and relevant personnel engaged in the production, operation, and use of medical devices shall actively take risk control measures to ensure product quality and safety.

 

　　The designatedagentofoverseas manufacturersshould cooperate with the sampling inspection of imported medical devices.

 

　　Article 6 [Classification of Sampling Inspections] Medical device quality sampling inspection is one of the technical means for post-market medical device supervision and should follow the principles of science, standardization, legality, and fairness.

 

　　According to different work purposes and implementation methods, medical device quality sampling inspections can generally be divided into supervisory sampling inspections and monitoring sampling inspections. Supervisory sampling inspections refer to sampling inspections where the test results can be used as the basis for administrative penalties and announcements. Monitoring sampling inspections refer to sampling inspections where the test results are not used as the basis for administrative penalties and announcements.

 

　　Article 7 [Information System] The National Medical Products Administration organizes the establishment of a national medical device quality sampling inspection information management system to provide technical support for sampling inspection work management.

 

　　Provincial drug supervision and management departments should strengthen the informatization construction of medical device quality sampling inspection work within their administrative regions.

 

　　Chapter 2 Plans and Programs

 

　　Article 8 [Sampling Plan] The National Medical Products Administration and provincial drug supervision and management departments shall formulate annual medical device quality sampling inspection plans and arrange medical device quality sampling inspection work in accordance with the requirements of clear objectives, prominent priorities, effective coverage, and overall coordination.

 

　　The medical device quality sampling inspection plans formulated by provincial drug supervision and management departments should be consistent with the objectives of the national medical device quality sampling inspection plan, have different focuses, complement each other, and avoid duplication.

 

　　According to changes in the regulatory situation, the drug supervision and management departments organizing sampling inspections may adjust the medical device quality sampling inspection plan.

 

　　Article 9 [Sampling Varieties] The following medical devices may be prioritized for sampling inspection in national medical device quality sampling inspections:

 

　　 (1) Those with high safety risks that require strict supervision;

 

　　 (2) Those with large clinical use, wide range of users, and broad application scope;

 

　　 (3) Those with many complaints and reports and high public attention;

 

　　 (4) Those whose quality problems may be indicated by adverse event monitoring;

 

　　 (5) Those whose product quality is easily affected by storage and transportation conditions;

 

　　 (6) Others required by supervision.

 

　　The following medical devices may be prioritized for sampling inspection in provincial medical device quality sampling inspections:

 

　　 (1) Products registered or filed in this administrative region;

 

　　 (2) Products not included in the national medical device quality sampling inspection varieties but with higher product safety risks;

 

　　 (3) Products included in the previous year's sampling inspection plan but not actually sampled;

 

　　 (4) Products that did not meet the regulations in previous sampling inspections;

 

　　 (5) Products whose quality problems may be found in daily supervision, adverse event monitoring, etc.

 

　　 (6) Others required by supervision.

 

　　Article 10 [Sampling Plan] Departments organizing medical device quality sampling inspections shall formulate sampling plans based on the plan, mainly including the following content:

 

　　 (1) Inspection varieties and planned samplingenterprisesScope;

 

　　 (II) Testing basis and items;

 

　　 (III) Testing institutions responsible for testing and retesting.

 

　　Chapter 3 Inspection Sampling

 

　　Article 11 [General Requirements] The drug supervision and administration department undertaking medical device sampling shall, in accordance with the plan formulated by the superior drug supervision and administration department and combining with the actual situation, formulate an implementation plan for the quality spot-check and inspection of medical devices within this administrative region. The implementation plan shall highlight the requirements of local medical device supervision work.

 

　　Article 12 [Sampling Institutions] The drug supervision and administration department may complete the sampling work by itself, or it may entrust a medical device supervision and technical institution with the corresponding work capability to conduct the sampling.

 

　　Article 13 [Sampling Personnel] The sampling unit shall be equipped with sampling personnel with professional sampling capabilities. The sampling personnel shall be familiar with professional knowledge of medical devices and relevant laws and regulations on medical device management.Regulations。

 

　　When performing on-site sampling tasks, sampling personnel shall not be less than2 persons. When sampling, they shall present relevant documents to the sampled unit. In principle, the same person should not undertake both the sampling and testing work at the same time.

 

　　Article 14 [On-site Inspection] When performing sampling tasks, sampling personnel shall conduct necessary on-site inspections in accordance with the law. If problems affecting the quality of medical devices or other illegal or irregular behaviors are found, the sampling shall be terminated, and the relevant situation shall be promptly reported to the administrative supervision department with jurisdiction. Sampling personnel may conduct recording through methods such as taking photos, videos, and audio recordings.

 

　　Article 15 [Sampling Location] Sampling shall be conducted by sampling personnel at the site where the sampled unit stores medical devices. Among them, when sampling from production enterprises and import general agents, it may be sampled from the sample library if necessary. Sampling from the medical device internet transaction link is generally conducted in the offline medical device warehouse that is consistent with the online one.

 

　　Article 16 [Sample Extraction] The extracted samples shall be products that have passed acceptance inspection and have been put into storage for sale (use), and shall be confirmed by the sampled unit. Samples shall be randomly extracted and shall not be selected and provided by the sampled unit itself.

 

　　Article 17 [Exceptional Circumstances] In any of the following circumstances, it shall not be included in the sampling scope in principle:

 

　　 (I) The sampled unit does not have the products listed in the sampling plan;

 

　　 (II) There is sufficient evidence to prove that the intended sample product is for non-sales purposes such as scientific research;

 

　　 (III) There is sufficient evidence to prove that the intended sample product is for export only by the enterprise;

 

　　 (IV) The product or label, packaging, or instructions bearwords such as "trial production," "processing," or "sample".

 

　　Article 18 [Material Inspection] Sampling personnel shall request the materials, attachments, or supporting products required for spot-check inspection. The sampled unit shall cooperate and proactively provide the following materials:

 

　　 (I) Product registration certificate/registration and filing certificate;

 

　　 (II) Product technical requirements registered or filed;

 

　　 (III) Records related to production, operation, and use;

 

　　 (IV) Medical device entrusted production agreement;

 

　　 (V) Attachments required for conducting inspection;

 

　　 (VI) Other attachments and materials that need to be provided.

 

　　Article 19 [Sampling Documents] Sampling personnel shall use special seals to seal samples on site, fill in the "Medical Device Sampling Record and Certificate" as required, and have the sampling personnel and relevant personnel of the sampled unit sign and affix the valid seals of the sampling unit and the sampled unit respectively; at the same time, they may request the sampled unit to provide copies of relevant materials and certification documents as needed, and affix the valid seal of the sampled unit.

 

　　If the sampled unit refuses to sign or affix a seal, the sampling personnel shall make a note and sign on the "Medical Device Sampling Record and Certificate".

 

　　Article 20 [Failure to Sample] If the sampled unit cannot provide samples due to certain reasons, it shall explain the reasons and provide relevant proof. Sampling personnel shall fill in the relevant records. After reviewing the relevant production, sales, and use records, the sampling personnel may organize a second sampling of the unit or track sampling to other links. The department responsible for drug supervision and administration in the location of the relevant unit shall cooperate.drugssupervision and administration

 

　　Article 21 [Information Acquisition] The medical device testing institution undertaking the medical device spot-check testing task (hereinafter referred to as the undertaking testing institution) shall obtain the product technical requirements and other materials required for testing from the national medical device review and approval system.

 

　　Article 22 [Storage and Transportation] The sampling unit shall send or mail the samples, sampling documents, and relevant materials to the undertaking testing institution within the prescribed time limit.

 

　　The extracted samples shall be stored and transported according to their prescribed storage conditions.

 

　　Article 23 [Restricted Behaviors] Sampling personnel shall not engage in the following behaviors during the sampling process:

 

　　 (I) Unauthorized opening or replacement of samples after sample sealing;

 

　　 (II) Disclosure of the sampled unit's commercial and technical secrets;

 

　　 (III) Other behaviors that affect the fairness of sampling.

 

　　Chapter 4 Inspection Management and Report Delivery

 

　　Article 24 [Inspection Principles] The medical device testing institution shall be responsible for the spot-check testing work it undertakes and shall conduct testing work in accordance with the medical device testing technical specifications and the principles of science, independence, objectivity, and fairness.

 

　　Article 25 [Sample Verification]}] The testing institution shall verify the appearance, condition, seals, packaging, and other factors that may affect the test results of the submitted samples, as well as the sampling certificate, tamper-evident measures, signatures, and seals, and sign for them after confirmation.

 

　　If there are factors that may affect the determination of the test results, the testing institution shall refuse to accept the samples, explain the reasons to the sampling unit, return the samples, and report the relevant situation to the drug supervision and administration department responsible for organizing the sampling inspection.

 

　　Article 26 [Testing Requirements] The inspection shall be carried out strictly in accordance with the basis, items, methods, and work requirements specified in the sampling plan. If the sample is invalid or other circumstances make the inspection impossible during the inspection process, the testing institution must truthfully record the situation, provide sufficient supporting materials, and report the relevant situation to the drug supervision and administration department responsible for organizing the sampling inspection.

 

　　Article 27 [Testing Time Limit] Unless otherwise specified in the sampling plan, the testing institution should, in principle, issue the test report within40 working days from the date of receipt of the sample; in special circumstances requiring an extension, approval shall be obtained from the drug supervision and administration department responsible for organizing the sampling inspection.

 

　　Article 28 [Quality Control] The testing institution shall be responsible for the test reports issued. The test reports shall be standardized in format, truthful and complete in content, accurate in data, and clear in conclusions.

 

　　The preservation period of the original inspection records and inspection reports shall be no less than5 years.

 

　　Article 29 [Report Delivery] The testing institution shall submit or send the test report as per the stipulated time. If the test result is non-compliant, the test report and a copy of the sampling certificate and other materials shall be transmitted to the provincial drug supervision and administration department where the sampled unit is located and the provincial drug supervision and administration department where the labeled manufacturer is located within2 working days after the issuance of the test report.

 

　　The drug supervision and administration department shall, within5 working days from the date of receipt of the test report with a non-compliant conclusion, organize the forwarding of the test report to the sampled unit and labeled manufacturer within its jurisdiction.

 

　　Article 30 [Sample Disposal] Samples with compliant test results shall be returned to the sampled unit in a timely manner three months after the issuance of the test report. If the samples cannot be returned due to damage or loss caused by the inspection, the sampled unit shall be informed of the situation. Samples with non-compliant test results shall be returned to the relevant drug supervision and administration department three months after the release of the test result notice.

 

　　The relevant drug supervision and administration departments and the sampled units shall receive the samples within the prescribed time limit. If they fail to cooperate after the deadline, the samples may be disposed of by the testing institution.

 

　　Article 31 [Inspection Behavior Standards] Testing institutions and inspectors shall not engage in the following behaviors during the inspection process:

 

　　 (1) Replacing samples;

 

　　 (2) Concealing or altering test data or issuing false test reports;

 

　　 (3) Disclosing the technical secrets of the parties concerned;

 

　　 (4) Unauthorized release of sampling inspection information;

 

　　 (5) Other behaviors that affect the fairness of the test results.

 

　　Chapter 5 Retesting and Disposal

 

　　Article 32 [Retesting Application] If the sampled unit or labeled manufacturer has objections to the test results, it may submit a retesting application to the retesting institution specified in the testing plan within7 working days from the date of receipt of the test report. The testing institution shall not refuse without justifiable reason. Applications submitted after the deadline will not be accepted.

 

　　Article 33 [Retesting Acceptance] The following materials shall be submitted for retesting application:

 

　　 (1) "Retesting Application Form" with the official seal of the applicant unit;

 

　　 (2) A complete copy of the original test report;

 

　　 (3) Original legal representative authorization letter;

 

　　 (4) Identity certificate of the person in charge;

 

　　 (5) Proof of validity period;

 

　　 (6) Other materials that need to be explained.

 

　　Article 34 [Non-acceptance] The retesting institution shall, within3 working days of receiving the retesting application, review the materials and make a written decision on whether to accept it, and report to the drug supervision and administration department responsible for organizing the sampling inspection on the same day. Under any of the following circumstances, the retesting application shall not be accepted:

 

　　 (1) Test items specified in the sampling plan that are not subject to retesting;

 

　　 (2) Samples that cannot meet the retesting quantity requirements, are beyond the expiration date, or have an insufficient expiration date to complete the retesting;

 

　　 (3) Retesting application not submitted within the specified time limit or retesting already accepted;

 

　　 (4) Failure to pay the retesting fees in accordance with the regulations;

 

　　 (5) Special reasons lead to the inability to achieve the retesting purpose with the retained samples.

 

　　Article 35 [Sample Transfer] The retesting institution shall, within3 working days from the date of making the acceptance decision, issue a sample requisition notice to the original testing institution, which shall provide the sample within 5 working days.

 

　　Both testing institutions shall carefully and properly transfer the samples.

 

　　Article 36 [Retesting Implementation] The retesting shall be conducted in accordance with the inspection requirements and judgment principles specified in the original sampling plan to issue a test report. In principle, no new samples or materials shall be introduced.

 

　　The retesting institution generally shall issue the test report after receiving the retesting samplesRetesting conclusions should be reached within 15 working days, and the test report should be delivered to the provincial drug supervision and administration departments of the production unit and the sampled unit, the unit applying for retesting, and the original testing institution within 2 working days from the date of issuance of the test report. In special circumstances requiring an extension, approval should be sought from the drug supervision and administration department that organized the sampling and testing.

 

　　The retesting conclusion issued by the retesting institution is the final test conclusion.

 

　　Article 37 Retesting Fees The unit applying for retesting shall pay the retesting fee in advance to the retesting institution. If the retesting conclusion is inconsistent with the original test conclusion, the retesting fee shall be borne by the retesting institution.

 

　　If there are other special provisions by the relevant departments of the State Council or the relevant departments of the provincial people's governments, those provisions shall prevail.

 

　　Chapter Six Supervision and Management

 

　　Article 38 Product Confirmation After receiving the test report with a conclusion of non-compliance, the sampled unit and the labeled production enterprise shall Confirm the sampling and testing situation.

 

　　If the labeled production enterprise denies that it produced the product, it shall provide sufficient and accurate supporting documents. The provincial drug supervision and administration department at the location of the labeled production enterprise shall organize an investigation and verification, and report the verification results to the drug supervision and administration department at the location of the sampled unit. For products verified as not being produced by the labeled enterprise, the drug supervision and administration departments at the location of the sampled unit and the labeled production enterprise shall cooperate and jointly verify the source of the problematic products.

 

　　Article 39 Corrective Measures After learning that a product does not meet the regulations, the production enterprise and the sampled unit shall fulfill the following obligations:

 

　　 (1) Implement product recall and issue recall information;

 

　　 (2) Conduct self-inspection and rectify relevant problems;

 

　　 (3) Adopt necessary risk control measures based on the results of the investigation and assessment.

 

　　During the application for retesting, risk control measures for non-compliant products should continue to be implemented.

 

　　Article 40 Investigation and Handling The drug supervision and administration department with jurisdiction over the relevant units involved shall investigate and handle the non-compliant results and other problems found in the sampling and testing. Cases meeting the filing conditions shall be filed and investigated and dealt with in accordance with regulations, and the results shall be made public as required. If a crime is suspected, the case shall be transferred to judicial organs for handling in accordance with the law. At the same time, the sampled unit and the labeled production enterprise shall be urged to fulfill their relevant obligations.

 

　　The retesting period does not affect the investigation and control of non-compliant products.

 

　　Article 41 Risk Control When the testing institution discovers the following situations during the testing process, it shall immediately notify the provincial drug supervision and administration department at the location of the production enterprise in writing, and simultaneously send a copy to the drug supervision and administration department organizing the sampling and testing of medical devices:

 

　　 (1) Serious quality and safety risks that require immediate control measures;

 

　　 (2) Suspected illegal and irregular production activities;

 

　　 (3) Multiple batches of products from the same enterprise fail to meet the regulations, indicating serious problems with the quality system.

 

　　The provincial drug supervision and administration department at the location of the production enterprise shall immediately organize an investigation and verification of the relevant situation, promptly adopt corresponding risk control measures, and seriously investigate and deal with the matter according to law.

 

　　Article 42 Information Sharing The drug supervision and administration department organizing the sampling and testing shall promptly inform relevant functional departments of major risks found in the sampling and testing. Relevant functional departments should actively investigate risks, take effective measures, and strengthen supervision.

 

　　Article 43 Penalty Mechanism Units and individuals engaged in the production, operation, and use of medical devices who refuse to accept sampling and testing without justifiable reason may be included in the credit joint penalty mechanism by the drug supervision and administration department.

 

　　Article 44 Administrative Responsibility Units and individuals participating in the sampling and testing work shall regulate their work behavior in accordance with the law and shall not engage in the following behaviors that violate laws, regulations, and relevant disciplinary requirements:

 

　　 (1) Unauthorized release of sampling and testing information;

 

　　 (2) Disclosure of relevant information on sampling and testing samples;

 

　　 (3) Accepting gifts from the units being sampled and tested;

 

　　 (4) Seeking other improper benefits by taking advantage of the sampling and testing work.

 

　　Chapter Seven Information Management

 

　　Article 45 Public Disclosure Entities Provincial-level and above drug supervision and administration departments are responsible for the public disclosure of information on the results of medical device quality sampling and testing organized by their departments.

 

　　No unit or individual may publish sampling and testing information without authorization.

 

　　If the public disclosure of medical device quality sampling and testing results is improper, it shall be corrected within5 days from the date of confirmation that the disclosed content is improper, within the original scope of disclosure.

 

　　Article 46 Information Management The drug supervision and administration departments should make full use of the medical device quality sampling and testing information system as a data support for strengthening the supervision and management of medical devices.

 

　　Article 47 Data Reporting National medical device sampling and testing work is uniformly included in the information system management. Provincial drug regulatory departments shall promptly submit relevant sampling and testing data and information as required.

 

　　Provincial medical device sampling and testing information should be promptly entered into the national medical device sampling and testing information system as required.

 

　　Chapter Eight Appendix Provisions

 

　　Article 48 Special Sampling and Testing According to the needs of medical device supervision and management work, the drug supervision and administration department may organize special sampling and testing as appropriate, and the relevant work content may refer to this method.

 

　　Article 49 Special Sampling and Testing Sampling and testing conducted due to supervision and inspection, monitoring and evaluation, or inspection and law enforcement work are not subject to restrictions on the number of samples, location, or sample status. The specific procedures may refer to this method.

 

　　Article 50 Sampling and Testing Funding The costs for medical device quality spot-check inspections are covered by the drug supervision and administration departments responsible for organizing the tasks, and they must strictly follow the relevant financial management regulations.

 

　　Article 51 [Effective Date] This method shall come into effect from the date of its promulgation. The "Regulations on the Supervision and Spot-Check Inspection of Medical Device Quality" (Food and Drug Administration Medical Device Supervision [2013] No. 212) shall be abolished simultaneously.2013〕212号）同时废止。