South Korea - Proposed Amendments to the "Enforcement Rule of the Medical Devices Act"

The Ministry of Food and Drug Safety (MFDS) is amending the "Enforcement Rule of the Medical Devices Act" as follows: 

1) Provisions governing delegated matters concerning GMP conformity assessment for medical devices

2) Detailed procedures for the designation and renewal of technical documentation review institutions

3) Expansion of the scope of exemptions from post-market surveillance for orphan medical devices