On July 10, 2015, the National Bureau of Medical Device Manufacturing Quality Management Standards Appendix Sterile Medical Devices, Medical Device Manufacturing Quality Management Standards Appendix Implantable Medical Devices, Medical Device Manufacturing Quality Management Standards Appendix In Vitro Diagnostic Reagents, which are applicable to sterile, implantable, and in vitro diagnostic reagent products, respectively. However, due to the implementation time is October 1 this year, so the current provincial bureaus are still in accordance with the trial implementation of many years of "Medical Device Manufacturing Quality Management Standards Sterile Medical Devices Implementation Rules and Inspection and Evaluation Criteria (Trial)" (State Food and Drug Administration Measures 〔2007〕 No. 835), "Medical Device Manufacturing Quality Management Standards Implantable Medical Devices Implementation Rules and Inspection and Evaluation Criteria (Trial)" (State Food and Drug Administration Measures 〔2007〕 No. 836) 2007] No. 836), "in vitro diagnostic reagents quality management system assessment of the implementation of the provisions (for trial)" "in vitro diagnostic reagent production implementation rules (for trial)" and "in vitro diagnostic reagent production enterprises quality management system assessment evaluation criteria (for trial) 〉 Notice" (State Food and Drug Administration, mechanical [2007] 239 No.) to implement the requirements of the inspection.
Active medical devices, is still in accordance with the "medical device production enterprise quality system assessment measures" (Bureau Decree No. 22) and "medical device production quality management standard" requirements to check.
2, when to submit an application for verification of quality management system of medical devices?
Applicants for registration of Class III medical devices shall submit system verification information to the provincial, autonomous regions, municipalities directly under the Central Food and Drug Administration within 10 working days after the acceptance of the application for registration;
The new regulations do not specify the time for Class II medical devices to submit a system verification application; however, at present, different provinces and cities have different requirements. For example: Jiangsu Province in the submission of medical device registration application information and submit a system verification application form, but the Drug Administration will wait until after the registration information issued by the complementary, before notifying the production enterprises to submit the system verification of other information; Beijing, Shanghai, Sichuan Province, is in the registration information submitted, to be received by the Food and Drug Administration notice to submit a system verification application; Guangdong Province, it is listed as a non-administrative licensing, the implementation of the production enterprise Self-application mode: enterprises can complete the design verification, to obtain qualified registration test report to apply for system verification, but also in the registration process, apply for system verification, the verification report and registration of additional information submitted together.
There is no specific implementation method or rule for system verification of imported registered products.
3, specifically by which department to carry out quality management system verification of medical device registration?
Domestic Class II, Class III medical device registration quality management system verification, by the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration to carry out; imported medical devices registered quality system verification by the State Food and Drug Administration quality management system inspection of technical institutions in accordance with relevant requirements.
4, system verification of the time limit is how long?
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration required within 30 working days, according to the relevant requirements to complete the system verification. Quality management system verification time is not calculated in the review time limit.
5, the production of enterprises need to participate in the verification of what personnel?
It is recommended that all responsible personnel in the quality system architecture diagram must participate, including all management, all positions, especially key positions, and require the presence of personnel with a high degree of practical ability.
6, what are the specific preparations for the production enterprises to meet the audit?
a) before the audit, confirm the person in charge of the audit and the personnel involved in the audit, and the audit of the personnel to carry out a detailed division of labor;
b) carry out a thorough self-examination or simulated audits, according to the results of the necessary rectification;
c) before the inspection of a comprehensive health cleaning;
d) check the area of the signs and
h) Prepare a company and product introduction, can be considered in the form of PPT in the first meeting to show the audit team, the introduction time is recommended to be no more than 15 minutes.
7. What is the focus of system verification?
In the verification process, while the authenticity of the samples used in the enterprise registration test samples and clinical trials for verification. Focus on access to the design and development process to implement planning and control of the relevant records, procurement records for the production of samples, production records, inspection records and sample observation records.
Design and development records should focus on the review of design inputs and design outputs, the record of the design and development outputs to meet the requirements of the design and development inputs; pay attention to the signature in the record should be hand-signed, pay attention to the logic and reasonableness of the record; retain the inspection report, after rectification of the qualified items of the design of the change records; audit team will also focus on the design and development of the record whether the application for registration of all models to be covered by the integrity of the record. registration of all models.
Procurement records should pay attention to the source of procurement and qualified suppliers to match, pay special attention to the site material information, material information in the record and the registration of material information consistency and traceability.
Inspection records should pay attention to the original records of inspection, the ability and authorization of inspectors, and the consistency of the equipment and reagents used with the actual situation.
Production records should consider traceability and material balance issues, to prevent the production records will be retained in the number of samples, the number of test is ignored.
Sample observation records should be concerned about the sample observation inspection records, this part is usually easy to be ignored.
8, what are the requirements of the production company's samples and records?
1) At least include all specifications and models of products to be registered in the application form for registration of medical devices, organize the information, samples and records to be checked.
2) Records need to be detailed and traceable, and the original records are well kept.
3) On-site inspection of the records, should focus on checking: registered test batch and clinical trial batch records. Requirements for batch record information and test reports, clinical trial reports on the product information is completely consistent.
4) The need to stay in the sample of the product, to pay attention to the stay in the sample is consistent with the batch record information.
9. What kinds of system verification conclusions?
There are three kinds of verification conclusions: through the verification, rectification and review, did not pass the verification.
1) rectification review, the enterprise should be submitted to the original verification department within six months of a one-time application for review and rectification report. Not within the specified time to submit applications for review and rectification report, or rectification review still does not meet the "through the verification" requirements, the verification conclusion of the "rectification did not pass the verification"; rectification through the verification, the verification conclusion of the "rectification through verification".
2) did not pass the verification, the technical review body to put forward the review of non-registration, food and drug supervision and management departments to make the decision not to register.
10, rectification and re-examination should be dealt with?
Enterprises should be within six months (if any, or within the time limit required by the Food and Drug Administration) a one-time to the original verification department to submit an application for review and rectification report.
11, what are the precautions during on-site inspection?
1) set up a general manager, in advance of the unified planning and audit process;
2) the department heads should be familiar with the system and regulations, the positions of personnel familiar with their responsibilities, and have the ability to operate, before the audit, prepare for the audit information, to maintain the consistency of the site information and reporting information; arrangements for the day-to-day work, try not to be interfered with by other matters during the audit;
11, the on-site inspection what to pay attention to?
3) Selection of good accompanying personnel, accompanying personnel should be familiar with the system, have strong communication skills. In the audit, play a role in reminding and communication;
4) Auditors to the relevant departments to audit, to create sufficient conditions for them to talk, write, etc.
5) Familiarize themselves with and grasp the relevant information, and patiently and carefully answer the relevant questions. When evidential information is required, it should be presented quickly and accurately to speak with evidence.
6) If you can give a reasonable explanation for the problems in the audit, you should give it in time. There is no suitable reason, do not make too many explanations, not to mention the departments to pass the buck;
7) When the explanation is not adopted, do not conflict with the auditors, can be reflected to the representatives of the managers, in communication with the audit team to reflect in detail;
8) do a good job in the audit of the scheduling work, has been audited by the department should be audited as soon as possible in the audit of the contents of the transfer of the relevant departments are not audited to enable the non-audited departments to prepare for full preparation. Unaudited departments to be fully prepared.