The Ministry of Food and Drug Safety (MFDS) has issued an administrative notice on September 5 regarding amendments to the 'Medical Device Manufacturing and Quality Management Standards' aimed at reducing the burden of on-site inspections for medical device manufacturers. The MFDS will collect opinions on these changes until September 26.
Key Changes in the Amendment:
- Simplified Regular Inspections for High-Quality Manufacturers
Manufacturers with excellent quality systems will now have their regular inspections primarily conducted through document review, rather than on-site, and the inspection cycle will be extended from three to six years. The number of required submission documents is also reduced to six types. - Revised Conformity Assessment Criteria
For minor nonconformities with minimal impact on quality, the new criteria will allow conditional sales, provided corrective actions are completed within a specified timeframe. - Enhanced Standards for Quality Assessors
Qualification requirements for senior quality assessors will now include recognition of both domestic and overseas assessment experience. Additionally, assessors must complete mandatory training specified by the MFDS to maintain their qualifications.
These amendments aim to reduce regulatory burdens, accelerate product distribution, and enhance the reliability and professionalism of quality assessments in the medical device sector.
👉 For more details, visit MFDS Website.
