Medical Device Regulatory Notices.
[GMP Update] On-Site Verification of Corrective Actions (February 2024)
MFDS advised that where issues affecting quality management require an on-site follow-up—such as missing procedures or infrastructure qualification—the review body should discuss the situation with the company, stop the audit and agree on a follow-up visit. The applicable audit…
[GMP Update] Product Groups for Applications Before 13 November 2023 (February 2024)
Under Article 3(1) of the supplementary provisions to MFDS Notice No. 2023-31, certificates issued under the previous rules are interpreted in terms of the revised 64 product groups, based on the devices assessed for GMP conformity. For applications received before the revised…
[GMP Update] Intended-Use Differences Between Device Specifications and Licences (December 2023)
MFDS stated that the revised medical device GMP operating guidance consolidated application documents and enabled formal review of the device specification document's intended use, performance, directions and precautions. MFDS noted that the intended use stated by an overseas…
[GMP Update] Limiting Repeated On-Site Audit Postponements (December 2023)
MFDS stated that, at the time of the notice, requested on-site audit postponements were processed by rescheduling without a limit on the number of postponements. Repeated rescheduling of accepted applications can delay on-site audits for other companies.
[GMP Update] Ending the Sales-Suspension Grace Period (September 2023)
MFDS explained that a grace period had previously allowed sales where audit backlogs prevented completion before certificate expiry. With additional review bodies and auditors, it considered such backlogs unlikely to continue. The former grace period should therefore cease, with…
[GMP Update] Applying the Continuous-Process Approach (September 2023)
Under the GMP application guide's manufacturing-site instructions, only sites performing key manufacturing processes should be named on the certificate. Applicants should review the relationships between the sites' QMSs and list only those sites performing key processes, rather…
[GMP Update] Combining Batch Periodic Applications with Other Audits (September 2023)
MFDS noted that review bodies differed on combining a batch periodic audit application with change or additional audits, which could confuse applicants. It advised against combining them, in keeping with the original purpose of batch periodic applications.
[GMP Update] Signature Requirements for Submitted Documents (September 2023)
MFDS stated that signatures or seals from the quality manager were not required on documents other than the quality manual. Applicants had requested a single replacement declaration, corresponding to the former site preparation certificate removed by the GMP amendment, instead…
[GMP Update] Cleanroom Entry/Exit Procedures in Document Review (September 2023)
Sites with cleanrooms must submit documents covering clean zones, cleanliness levels, entry/exit, personnel and material flows, and operation and maintenance. For document review, MFDS advised assessing clean zones, cleanliness levels and cleanroom operation/management…
[GMP Update] Handling Omitted Audit Information (June 2023)
If an on-site audit reveals intentionally or accidentally omitted documents or incorrect application information, the planned audit duration may need to be revised. MFDS advised establishing a response for such cases. Example: The site's actual employee count is more than twice…