On April 3, 2026, the Ministry of Food and Drug Safety (MFDS) of Korea announced a draft partial amendment to the Enforcement Regulations of the Medical Devices Act.
The purpose of this draft partial amendment is to stipulate the detailed matters delegated to the sub-regulations, following the establishment of legal grounds for the conformity assessment of medical device manufacturing and quality management standards (GMP), the revocation of certificates of conformity, corrective orders, and the renewal of designations for quality management and technical document review agencies.
The key details are as follows.
1) Provisions on delegated matters concerning conformity assessment of medical device manufacturing and quality management standards (GMP)
- This regulation aims to define specific details delegated by the amended Medical Devices Act, including legal frameworks for GMP conformity assessment, auditor management (appointment and training), designation and renewal of assessment agencies, and administrative actions such as issuance, revocation, and corrective orders for certificates.
2) Expansion of Post-Market Surveillance (PMS) exemptions
- While manufacturers of orphan medical devices are mandated to conduct post-market surveillance (PMS), difficulties in implementation can lead to supply disruptions, potentially resulting in treatment gaps for patients with rare diseases. Therefore this amendment aims to exempt orphan medical devices that meet specific criteria from PMS requirements to prevent supply interruptions and ensure timely access to treatment.
Public comments on the draft amendment will be accepted until May 13.
Please refer to the attached document below.
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