The Korean Food and Drug Administration (KFDA) is in the process of changing its pre-approval system. The plan is to implement the new system partially within this year. The KFDA has presented a draft regulation of this change. Under the proposed new system, some foreign medical device manufacturers will have to receive a KFDA good manufacturing practices (GMP) certification to export their devices to Korea. This draft regulation is a bit vague and some industry experts believe that some of the changes have gone too far.
Once the new system is implemented, a Korean importer should submit the following Quality Assurance (QA) documents to the KFDA or its authorized 3rd party prior to the foreign site-inspection. The KFDA or the 3rd party will review the submitted documents and decide whether or not an onsite inspection is required. If the KFDA considers the documents insufficient, an onsite-inspection of all the relevant manufacturing sites (including some outsourced manufacturers) would be required.
Required documents may include:
- Manufacturer’s organization information (the number of QA associated employees)
- The list of the products being produced in the sites
- ISO 13485 certificate
- Manufacturing facility description (including floor plan, production facility and equipment)
- Major suppliers and the scope of their responsibilities
- Audit report received from other QA inspection body (i.e. a notified body), if available
- Quality Manual (including Quality Policy)
- Device Master File (including the sterilization process, software validation and other specific manufacturing processes) of the concerned device to be distributed in Korean market
- IFU and/or Operation/Service manual