In a move that is likely to ease the way for foreign medical device manufacturers, the KFDA is planning to eliminate certain requirements for certificates of product approval. Manufacturers must currently submit a copy of the product approval in the country of manufacture, the approved technical file, the approved type test, and a list of the facilities.
Currently, medical devices manufactured outside of Korea must be approved in their country of manufacture before they can receive product approval in Korea. The manufacturer must submit a valid certificate issued by the government within the last two years. However, the KFDA is currently taking steps to eliminate this requirement. In the future, foreign device manufacturers would be able to apply for product approval in Korea before receiving approval elsewhere. This change is expected to be implemented mid-2009.
While the approved technical file will still be necessary, the KFDA also plans to eliminate the requirements for a copy of the approved type test, as well as a list of the manufacturing facilities. The type tests are conducted by a KFDA-registered third-party lab that physically tests samples submitted by the manufacturer. These changes should also be implemented mid-2009.
To make the product approval process more efficient, the KFDA also recently announced a new risk classification system, which will be effective beginning July 1, 2009. The current risk classification system has four classes that encompass 1,012 classifications: Class I, or low risk, contains classifications such as surgical instruments; Class II, or low-moderate risk, contains classifications like hypodermic needles; Class III, high-moderate risk, contains devices such as orthopedic implants; and Class IV, high risk, contains devices such as implantable defibrillators. The new system will contain around 2,000 classifications separated into the four risk classes.
For pre-market approval, device manufacturers with Class II-IV devices are required to obtain a certificate of product approval, a device business license, and KGMP certification. The product approval certificate and business license are permanent, but the KGMP certificate is only valid for three years and will need to be renewed. Manufacturers of Class I devices only need a certificate of product notification rather than the certificate of product approval, although the business license and KGMP certification are still required.