The Beijing Municipal Food and Drug Administration released its directive on GMP certification of medical device manufacturers under its jurisdiction: 156 sterile, implantable medical device manufacturers, 119 IVD reagent manufacturing enterprises, and 111 manufacturers of Class Ⅲ medical devices have met the requirements.
According to the “Notice of Beijing Municipal Food and Drug Administration’s Implementation Plan for Good Manufacturing Practices of Medical Device Production” released on March 16, 2016, the applicant is exempted from on-site inspection after the registration of medical device quality management system is qualified.
October 1st, 2014 – newly founded medical device manufacturers and existing ones should meet the standards when upscaling the production of Class III medical devices, and moving/adding production sites.
January 1st, 2016 – all Class III medical device manufacturers should meet the standards.
January 1st, 2018 – all medical device manufacturers should meet the standards.
It is applicable to the inspection of registration the Class Ⅱand Ⅲmedical device quality management system;
It is applicable to the on-site inspection of “Medical Device Production License” of Class Ⅱ and Ⅲ medical devices;
It is applicable to various kinds of supervision and inspection of the manufacturers’quality management system.
Who & What? Who is responsible for what in the Supervision?
The Beijing Municipal Food and Drug Administration organised and coordinated the implementation and the training of the “Practices”.
The Beijing Municipal Centre for Medical Device Technical Evaluation organised the verification of the registration management quality system and the on-site inspection of the non-literal changes to production address in the “Medical Device Production License”.
More from the Directive…
All district bureaus, and all bureaus which are directly under district bureaus should conduct production license on-site inspection, supervision within their jurisdictions, and assign inspectors to participate in the on-site verification.
The Municipal Medical Device Testing Institute and the Municipal Adverse Drug Reaction Monitoring Centre should assign inspectors to participate in the on-site inspection.
The acceptance departments of the Municipal Food and Drug Administration of all district bureaus and all bureaus directly under district bureaus should deliver relevant information of the on-site inspection.
The acceptance department of the Municipal Food and Drug Administration should also send the verification results of Class III medical device.
How to implement?
Registration verification for quality management system
- Upon acceptance of the application, the applicant should submit verification information to the Municipal Food and Drug Administration within 10 working days. If the submittedinformation meets the requirements, the Municipal Medical Device Evaluation Centre will complete the verification within 30 working days.
- The authenticity of the registered testing samples and samples for clinical trials will be verified during the quality system verification.
- If the quality system verification is required due to the changes to the items of registration license, it should be executed in accordance with the regulations of the Notice.
- The results of the quality system verification include “Verified”, “Re-verify After Rectification”, “Verified After Rectification”, “Verification Failed After Rectification”, “Verification Failed”.
– The result is “Verified” when no non conformity is found.
– On-site re-verification will not be conducted if the general items alone are non compliant but do not directly affect the product quality.
The result is “Verified” if the rectification was done within 30 days and the items were qualified. “Re-verify After Rectification” if the items are non compliant;
The result is “Verified After Rectification” if the items passed the re-verification after the rectification.
– The result is “Verification Failed” if the key items were unqualified, or the general items alone are non compliant or could directly affect the product quality; “Verification Failed After Rectification” if the relevant information was not submitted within the time limit, or the items failed the re-verification after the rectification.
- For the Class III medical devices, the Municipal Food and Drug Administration will send the original verification result notice to the Medical Device Evaluation Institution of the CDFA within 10 working days after the verification is concluded.
On-site inspection requirements for Production license
- The on-site inspection will not be conducted after the application for the quality management system verification is qualified.
- For those applications with non-literal changes to the production addresses, the district bureaus and the bureaus directly under district bureaus should examine the submitted information, and the Municipal Centre for Medical Device Technical Evaluation should conduct the on-site inspection.
- The results of the on-site inspection include “Verified”, “Re-verify After Rectification”, “Verification Failed”.
– The result is “Verified” if no non conformity was found.
– The result is “Re-verify After Rectification” if the general items alone were in non compliance but do not directly affect the product quality. The rectification should be done within 30 days and the rectification report should be submitted to the original evaluation department, and then get “Verified” if the items were qualified.
– The result is “Verification Failed” if the key items are in non compliance , or the general items alone were non compliant or could directly affect the product quality; “Verification Failed” if the rectification report was not submitted within the specified time limit, or when the non conformity still exist in the re-verification.
Daily supervision and inspection requirements
The manufacturers should suspend production for rectification when the key items are in non compliance , or when the general items alone were non compliant or could directly affect the product quality; the manufacturers should rectify within time limit if the general items are non compliant but do not directly affect the product quality.
Other on-site inspection requirements
- The on-site inspection will not be conducted if the on-site re-verification is not needed.
- The process takes 1 to 3 days.
- The team leader will take the responsibilities. For the on-site inspection that relates to the system verification and the application for non-literal changes to the production addresses, the Municipal Centre for Medical Device Technical Evaluation should assign personnel to build an inspection team and determine the team leader, the district bureaus and the bureaus directly under district bureaus should assign at least one inspector. In addition, it is allowed to invite relevant experts or entrust an agency as the third party.
- The inspection should be terminated if the manufacturers are suspected of being involved in illegal business operations or the undone on-site inspection due to their own reasons; for the manufacturers whose production processes are done by other manufacturers, the inspection of the component manufacturers can be extended depending on the circumstances.
