Changes in Korea’s Pre-Approval System For Medical Devices

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:

  1. Manufacturer’s organization information (the number of QA associated employees)
  2. The list of the products being produced in the sites
  3. ISO 13485 certificate
  4. Manufacturing facility description (including floor plan, production facility and equipment)
  5. Major suppliers and the scope of their responsibilities
  6. Audit report received from other QA inspection body (i.e. a notified body), if available
  7. Quality Manual (including Quality Policy)
  8. Device Master File (including the sterilization process, software validation and other specific manufacturing processes) of the concerned device to be distributed in Korean market
  9. IFU and/or Operation/Service manual