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.

1. Increase in Medical Device Review Fees
 

2. Announcement of Guidelines for Disclosure of Medical Device Approval Information

• 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.

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.