The Ministry of Food and Drug Safety has issued new regulations on medical device classifications and grades, ensuring safety and efficacy through structured reclassification procedures and compliance with updated standards.
Classification Criteria:
- Performance and intended purpose of the device.
- Independent manufacturing and sale considerations.
- Combination of devices requiring specific classification.
Reclassification Process:
- Entities must submit documentation comparing similar devices.
- The Ministry will review and decide within 90 days.
- Regulatory Implementation:
- Manufacturers and importers must comply with new classification rules.
- Devices under previous approvals may continue until specified deadlines.
- Changes in classification numbers, item names, and grades will be recognized without requiring modification procedures.
- Amendments & Transitional Measures:
- New categories introduced, including in vitro diagnostic reagents for hematology, transfusion medicine, and clinical microbiology.
- Outdated classifications removed to align with updated safety standards.
- Smooth transition measures ensure compliance without requiring additional approvals.
- These regulatory changes aim to enhance medical device oversight, streamline classification processes, and ensure a clearer regulatory pathway for manufacturers.
Region: East Asia
Source: https://www.mfds.go.kr/brd/m_211/view.do?seq=14875&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
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