Starting here is a serie of posts related to Korean Regulation, the first one being about South Korea KGMP inspection requirements which is equivalent of the US Good Manufacturing Practice.

Quality system regulations (KGMP)

All Medical Devices are required to be manufactured under GMP. Premarket GMP audit is mandatory for all class II, III and IV devices and class I (sterile and measuring devices).

Certification of compliance to “Standards for manufacturing and quality management of Medical Devices“ (KGMP, similar to ISO 13485)
Both document review and site inspection conducted by 3rd party GMP inspector organization, the audit team accompanied by KFDA officer if necessary (see below)
Update every 3 years

Currently, a KFDA guideline was published on “GMP audit for foreign manufacturers of imported products” and implemented with the time frame:

Class IV: from April 8, 2012
Class III: from 2013
Class II/I (sterile and measuring): from 2014

In case of many manufacturing sites per importer, the manufacturing sites will be sampled per depending on the criteria of product risk, importing volume, PMS data, etc.

The following issues are not focused during TDR/SER (technical documentation review/Safety and efficacy review) process but during the GMP-audit:

Sterilization process validation
Risk management file

Here is a table of reference summarizing the requirements:

1」Manufacturers that have had KGMP non-compliance issues within three years or that have reported any safety or efficacy problems prior to an inspection will also undergo inspections (class 1, 2 : subject to a 3^rd party audit, class 3, 4 : subject to a joint audit)

2」 Can be replaced by documentation review if domestic importers have valid approval certificate for the manufacturer. Yet, Manufacturers that have had KGMP non-compliance issues within three years or that have reported any safety or efficacy problems prior to an inspection will also undergo inspections.

3」 Class 2,3,4 medical devices inspection may be executed through document review. Still, Manufacturers that have had KGMP non-compliance issues within three years or that have reported any safety or efficacy problems prior to an inspection will also undergo inspections (class 1, 2 : subject to a 3^rd party audit, class 3, 4 : subject to a joint audit).

4」importers representing several foreign manufacturers must have only one of those manufacturers undergo onsite audits (documentation review applies to the other manufacturers).

5」Manufacturers that have had no KGMP non-compliance issues within three years or that have not reported any safety or efficacy problems prior to an inspection will also undergo inspections by third-party auditors, who will then report findings to the KFDA for final decision

6」Any KGMP non-compliance issues in the previous three years will require a joint third-party and KFDA audit. Any safety and/or efficacy issues reported will also require a joint KFDA/third-party audit of a manufacturing site