Proposed Medical Device Regulation Amendments in Korea

On June 25, 2008, the Korea Food and Drug Administration (KFDA) drafted a proposal amending current medical device regulations. The KFDA is currently soliciting comments on this proposal until July 16, 2008.

The director of the KFDA will announce a “permitted standard,” official standards based on Korean and international regulations and standards. Each medical device will have certain standards depending on type and risk classification. However, the technical document review for Class II medical devices will be similar to Class III and IV medical devices.

Low risk medical devices that meet these “permitted standard” requirements will no longer need to submit a technical file when applying for product registration. Technical files are similar to 510(k) submission documents in the US. With this technical file exemption, the application process will decrease from 65 to 55 days.

In addition, the draft proposes simplification of experimental medical devices. Currently, applicants must apply to the following three parties to import experimental medical devices:

  1. Third party inspection organization
  2. District Food and Drug Administration
  3. Korean Medical Device Industry Association

With the new proposal, applicants would only need to consult a third party inspection organization and the Korean Medical Device Industry Association.

Qualification requirements for the third party inspection organization will also be decreased. At present, medical device inspections at these organizations must have 2 or more years of field experience. The draft proposes reducing this requirement to 1 year to facilitate increased recruitment. Through these changes, the KFDA hopes to ease market entry of medical devices.