Newsletter.
Regulatory developments in medical devices and IVDs,
market updates and insights from BCG
[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…
[GMP Update] Remaining Validity for Batch Periodic Applications
MFDS stated that the interpretation manual would recommend batch periodic audit applications for sites with no more than one year remaining on their certificates, reflecting the three-year audit cycle. Because batch applications are intended to reduce the burden on companies…
Revision of Korea's Medical Device GMP Operating Guidance
The operating guidance for Korea's medical device manufacturing and quality management standards (GMP) has been revised. The guidance aims to ensure accurate, consistent and transparent implementation of the medical device GMP standards by the personnel responsible.
Non-Conformity Findings in Medical Device KGMP Audits
A KGMP audit may result in a non-conformity decision where a violation of Korea's Medical Devices Act is identified. Common examples include:
Interpreting Requirements for Medical Device KGMP Audits
KGMP conformity assessments are official duties performed on behalf of the Minister of Food and Drug Safety, rather than private assessments, and are conducted in Korean. Manufacturers/importers should arrange an interpreter able to understand the language used at the site and…