Newsletter.
Regulatory developments in medical devices and IVDs,
market updates and insights from BCG
Medical Device Exports During Administrative Sanctions or After GMP Expiry
A suspension of manufacturing or importing prohibits the affected activity, while domestic sales and exports may remain possible. A sales suspension allows manufacturing and importing but prohibits domestic sales. Export eligibility requires case-specific assessment because the…
[GMP Update] Software Manufacturing Sites Sharing an Address
MFDS advised that two GMP certificates for the same address should be managed as a single certificate where different product groups have different periodic audit schedules, to simplify administration. However, consolidating under the certificate with the longer remaining…
[GMP Update] Certificate Entries for Medical Device Sets
For a device supplied as a set, MFDS advised listing only the final packaging site, which bears legal responsibility, on the front of the GMP certificate. Other manufacturing sites are listed on the reverse. MFDS stated that guidance already requires documents from each…
[GMP Update] Certificate Validity for Temporarily Deferred On-Site Audits
MFDS advised that sites whose on-site audits are temporarily deferred should receive certificates with the statutory three-year validity period. It stated that this approach was being implemented immediately, with revisions to the GMP operating guidance and interpretation manual…
[GMP Update] Documents Required for MDSAP-Based Review
MFDS advised that the review body's own inspection records may be omitted because they fall outside the scope of review using MDSAP audit results. A separate letter from the manufacturer explaining that the omitted records cannot be submitted is also unnecessary.
[GMP Update] Pest and Rodent Control Assessments (April 2024)
Pest and rodent control may be outsourced or managed in-house. MFDS advised reviewing whether the chosen methods and records comply with quality management requirements. Contact BCG for further information.
[GMP Update] Standardising Application Documents (April 2024)
MFDS advised that the following documents would be requested in addition to the application form and attachments required under the medical device GMP standards. [Additional Documents] ① Consent to collection, use and disclosure of personal information ② Copy of the business…
[GMP Update] Combined Medical Device and IVD Audit Duration (April 2024)
Following implementation of Korea's In Vitro Diagnostic Medical Devices Act in 2020, MFDS stated that it provided guidance to avoid duplicate audits where the same quality system applies. Sites manufacturing both medical devices and IVDs under the same QMS may undergo a combined…
[GMP Update] Medical Device UDI System Improvements (April 2024)
MFDS stated that site details can be viewed through the Medical Device Safety Portal by selecting Information Search → Enter UDI Code. The portal's UDI Tracking System route does not provide site lookup or camera-based searches.
[GMP Update] Determining Certificate Validity Dates (February 2024)
With online GMP application and processing implemented, MFDS advised establishing a consistent certificate issue-date rule for each quality management review body. Previously, audit results were reported to the regional MFDS office for both independent and joint audits, and the…
[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…