[MDREX NEWSLETTER] Recent Regulatory Updates Pertaining to.. Recent Regulatory Updates Pertaining to Medical Device Companies |
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This newsletter summarizes important regulatory updates from various government agencies that pertain to medical device companies. Companies planning to distribute products in Korea should consider the following information when establishing their market entry strategies.
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1. Increase in Medical Device Review Fees
- The Ministry of Food and Drug Safety (MFDS) announced a draft amendment to the Enforcement Rule of the Medical Devices Act to significantly increase the review fees for “newly developed medical devices” as follows:
- According to Article 8 of the Medical Devices Act, a “newly developed medical device” is defined as a product that fundamentally differs from previously approved products in terms of operating principles, performance, or intended use, etc. that, due to limited clinical data available during the approval review, require post-market surveillance (e.g., collecting patient information, adverse events, etc.) for 4 to 7 years, followed by a reassessment for approval. Additionally, newly developed medical devices can receive healthcare benefits under the National Health Insurance Act during the post-market surveillance period.
▶ Newly developed medical device approval review fee:
1,662,000 KRW → 98,430,000 KRW (over 59x, approx. 71,425 USD)
▶ Newly developed medical device technical document pre-review:
583,000 KRW → 55,240,000 KRW (over 94x, approx. 40,089 USD)
▶ Newly developed medical device clinical trial data pre-review:
1,219,000 KRW → 39,170,000 KRW (over 32x, approx. 28,426 USD)
* Note: 1 USD = 1,377.95 KRW
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2. Announcement of Guidelines for Disclosure of Medical Device Approval Information
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- To ensure the public's right to know, the MFDS has been disclosing materials submitted by medical device companies for approval reviews, in accordance with the Official Information Disclosure Act (Articles 8-2 and 9). However, the same Act principally excludes from disclosure “information pertaining to management and trade secrets of corporations, which, if disclosed, is likely to seriously undermine the legitimate interests of the corporations.”
- In compliance with the aforementioned legal requirements, the MFDS has been disclosing only a portion of the materials submitted for medical device approval reviews, largely due to the uncertainty in determining whether a material should be classified as a management/trade secret or not.
In response, the MFDS recently announced the guidelines stating the classification criteria for disclosable and non-disclosable information as described below:
▶ Disclosable :
- Shape and structure(excluding dimensions)
- Raw materials(including names of components, raw materials and
ingredients; excluding quantities/mixing ratios)
- Performance, Intended use, Instructions for use and precautions, etc.
▶ Non-disclosable :
- Manufacturing methods
- Test specifications
- Supplementary documents
- For reference, even if the submitted material is considered to be a disclosable information, medical device companies may make a written request for protection of the submitted data under Article 45 of the Medical Devices Act by providing legitimate reasons, such as pending patents, etc.
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3. Restrictions on Use of Hazardous Substances and Recovery/ Transfer/ Recycling Obligations for Electronic Medical Devices
- The Ministry of Environment has announced draft amendments to the Enforcement Decree of the Act on Resource Circulation of Electrical and Electronic Equipment and Vehicles (Articles 8 and 14), extending RoHS
- (Restriction of Hazardous Substances) and WEEE(Waste Electrical and Electronic Equipment) regulations to electronic medical devices. The restrictions on use of hazardous substances will take effect from January 1, 2028, while recovery/ transfer/ recycling obligations will apply from January 1, 2026.
- The amendment identifies ten substances to be considered as hazardous substances, which includes lead, mercury, cadmium, etc. It should be highlighted that the MFDS currently considers all refurbished medical devices, whether manufactured or imported, to be secondhand medical devices, requiring compliance with distribution regulations of secondhand medical device (such as secondhand medical device approval, inspection certification labeling, etc.) in accordance with the Medical Devices Act. This suggests a need for differentiated regulatory standards for refurbished products to be developed in the future.
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Please consider these updates when developing your medical device approval strategies. As a specialized consulting firm in the medical device field, MDREX promptly identifies domestic medical device regulations and supports manufacturers and importers in regulatory compliance.
For assistance with medical device regulations and market entry,
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1315-ho, B-dong, 167, Songpa-daero, Seoul, Republic of Korea
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