Using MDSAP Results for KGMP Certification in South Korea

1. Key takeaways

MFDS Public Notice No. 2023-79 allows desk review of the initial, additional, and change audit results of MDSAP to support acquisition of a KGMP certificate. Two boundaries apply: the periodic audit must still be conducted on site and cannot be replaced by MDSAP results, and a KGMP certificate obtained on this route carries the same validity as the MDSAP certificate.

The value of the arrangement is converting existing MDSAP audit results into evidence for the Korean KGMP and cutting duplicated audits. It does not change the structure of KGMP itself: the rules that it is mandatory for Classes 2-4, that the certificate is valid for 3 years, and that the periodic audit must be applied for 90 days before expiry all remain, except that on the MDSAP route the certificate validity follows the validity of the MDSAP certificate.

Non-applicable situations fall into 4 categories: safety and compliance, data submittability, audit status, and product scope. GRZAN screens the non-applicable situations at the assessment stage before deciding whether to take the MDSAP route.

2. Legal basis

The MDSAP route rests on the following instruments.

Applicability boundaries of the MDSAP route (per MFDS Public Notice No. 2023-79)

3. Expert insights

The desk review waives the travel, not the standard. MDSAP results can be used for desk review of the initial, additional, and change audits, but the substantive requirements of the review are not lowered: the audit organization still evaluates the submitted MDSAP audit evidence against the KGMP standards. GRZAN warns against reading this as trading an MDSAP certificate for a KGMP certificate: what is submitted are audit records and evidence, and what is evaluated is how far that evidence covers each KGMP element. Elements the evidence does not reach still need supplementation.

Tying certificate validity to the MDSAP certificate changes the expiry management logic. A regular KGMP certificate is valid for 3 years, but a KGMP certificate obtained on the MDSAP route has the same validity as the MDSAP certificate. The expiry node is therefore no longer set by the KGMP issuance date but by the MDSAP certificate’s validity. GRZAN tags the expiry source separately for such certificates in the compliance calendar, so the periodic audit application node 90 days before expiry is not missed by assuming the usual 3-year cycle.

The periodic audit must be conducted on site, forming a rigid floor on long-term cost. Even when the initial, additional, and change audits can all be completed by desk review, the periodic audit every 3 years must still be conducted on site. What a company can compress is the travel cost of the first three audit types; the cyclical on-site audit cannot be eliminated. GRZAN books the on-site audit in long-term budgets as a fixed recurring expense, not as an optimizable item (practical estimate).

Screen the non-applicable situations before discussing route selection. The non-applicable situations include: manufacturers found to have safety problems; those unable to submit data for confidentiality reasons; those requiring an updated audit; those found to have major deficiencies within MDSAP; those producing multiple types of medical products; and manufacturers of devices containing human-derived components or human tissue. Grouped into 4 categories: safety and compliance (manufacturers with safety problems, those with major MDSAP deficiencies), data submittability (unable to submit data for confidentiality reasons), audit status (requiring an updated audit), and product scope (multiple product types, devices with human-derived components or human tissue). GRZAN’s experience is that the product scope category is the one foreign manufacturers trigger most often, so screening should start there (practical estimate).

4. Practical recommendations

• Screen the four non-applicable categories before choosing the MDSAP route. Start with the product scope category (multiple product types, human-derived components or human tissue), which is recommended for first screening (practical estimate).
• Prepare evidence separately for the three usable audit types. Initial, additional, and change audits each map to different MDSAP audit records; do not mix them.
• Register the expiry source of MDSAP-route certificates separately. Their validity matches the MDSAP certificate and must not be extrapolated from the 3-year convention.
• Budget and schedule the periodic audit as an on-site event. The on-site audit every 3 years is rigid expenditure (practical estimate).
• Check submission lists against Guide-1349-01. Procedural requirements follow the MFDS guideline; missing items block the desk review from starting.

5. Verification checklist

• □ Non-applicable situation screening — compared item by item against the 4 categories; standard: none of the non-applicable situations is triggered.
• □ Audit type mapping — check the KGMP audit type to be applied for; standard: one of the initial, additional, or change types.
• □ MDSAP evidence completeness — check MDSAP audit record coverage against the KGMP elements; standard: every element has matching evidence and gaps are supplemented.
• □ Periodic audit arrangement — check the cycle and audit format; standard: arranged on the 3-year cycle and conducted on site.
• □ Certificate validity source — check the issuance basis; standard: an MDSAP-route certificate’s validity matches the MDSAP certificate.
• □ Periodic audit application timing — counted back from the expiry date; standard: the application has been scheduled 90 days before expiry.
• □ Guideline conformity — submission materials checked against Guide-1349-01; standard: the document list matches the procedural requirements.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team manages MFDS approvals, certifications and notifications, prepares equivalence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com