The Ministry of Food and Drug Safety (MFDS) is moving to ease regulations to stabilize the supply of medical devices used by patients with rare diseases. The agency also aims to enhance the transparency and reliability of its review system by codifying Good Manufacturing Practice (GMP) standards for medical devices into law.
The MFDS announced Sunday that it has issued a legislative notice for a proposed amendment to the Medical Device Act Enforcement Rules. The amendment includes detailed criteria for the GMP conformity recognition system. The revision is a follow-up measure after last year's amendment to the Medical Device Act established the legal basis for the GMP system.
The most significant change is the easing of regulations on orphan medical devices. Going forward, orphan medical devices with a track record of use overseas may be exempted from post-market surveillance. Post-market surveillance typically tracks safety and efficacy over four to seven years. In the rare disease sector, where patient numbers are small, conducting such surveillance has often proved difficult, leading to supply disruptions in some cases.
The MFDS expects the measure to reduce the burden on industry and improve treatment access for rare disease patients. Orphan medical devices are considered a critical supply area, as they often serve domestic patient populations of fewer than 20,000 or treat conditions with no alternative therapies.
The overall quality management system for medical devices is also being overhauled. GMP conformity recognition standards, previously governed by administrative notices, are being elevated to the level of law. This will clarify review criteria, procedures, and reviewer qualification requirements. Application procedures and document submission requirements for manufacturers and importers will also be specified in greater detail.
The amendment also systematizes the designation and renewal procedures for quality management review agencies and introduces a new obligation for the MFDS commissioner to publicly announce designations. Criteria for revoking conformity recognition and requirements for corrective orders have also been established to improve the predictability of the system.
Management of technical document review agencies will be strengthened as well. The validity period for agencies that review technical documents during the medical device approval process has been set at four years, with mandatory renewal applications required 180 days before expiration. The MFDS plans to reissue designation certificates 30 days before expiration when requirements are met, minimizing gaps in the review process.
Industry observers expect the amendment to deliver a dual benefit of regulatory clarity and supply stability. "This will help provide a more stable supply of medical devices needed by patients with rare and intractable diseases," said Kim Young-min, chairman of the Korea Medical Devices Industry Association.
An MFDS official said the revision aims to "build a field-oriented, rational safety management system," adding that "we will strengthen the competitiveness of the medical device industry through institutional clarification and regulatory improvement."