Regulations regarding the reevaluation of medical devices by the MFDS are expected to be partially revised.

-

 

Regulations regarding the reevaluation of medical devices by the MFDS are expected to be partially revised. Public comments will be accepted until January 17, 2024.


- To swiftly overcome public health crises, improvements have been made to exclude products designated as public health crisis response medical devices from reevaluation.


- Even in cases where there are domestically available alternative medical devices, improvements have been made to exclude products from reevaluation if they are deemed essential for stable public health supply support.





👉 Contact GCA

Tel. +82-31-360-8180
Email: forest.lee@gca-kr.com

Comments

Post a Comment

Popular posts from this blog

Strengthening core mineral supply chains and fostering the post-use battery industry ecosystem systematically

-
Image
  On December 13th, the government announced plans to enhance the competitiveness of the secondary battery industry during an emergency economic ministerial meeting.   A bill will be introduced by 2024 to systematically promote the post-use battery industry. A three-stage safety inspection system will also be implemented for the secure distribution and utilization of electric vehicles with used batteries and reusable products. Batteries meeting performance criteria are recognized as products from the dismantling stage, with extended storage periods for recycling and mandatory information input at each lifecycle stage through legislation. The patent review period for secondary batteries will be shortened from 21 to 10 months. Exemptions for electric sales permits will be granted to electric two-wheeler battery exchange services, and support will be provided for new markets like secondary battery subscriptions. Tax deductions for overseas resource development investments, sta
Read more

MSIT, Revises and Enforces Enforcement Decree of Radio Act to Improve Radio Regulations

-
Image
  Freepik The Ministry of Science and ICT announced that the revised Radio Wave Act Enforcement Decree, which relaxes regulations on radio wave utilization, will come into effect from March 26th. The main contents of the revised Radio Wave Act Enforcement Decree are as follows. 1. The full exemption of spectrum usage fees for small and medium-sized MVNOs (Mobile Virtual Network Operators) has been extended until 2024. Starting from 2025, spectrum usage fees will be gradually imposed. 2. The Unified Wireless Station Inspection Schedule System will be implemented. Multiple wireless stations located in the same installation site or operated by the same facility owner with different inspection schedules will be improved to allow for joint regular inspections. 3. The approval process for public 5G Integrated Repeaters (i5G) installed or equipped on robots, intelligent CCTVs, and others will be relaxed from a permit system to a notification system. 4. Reduction of Safety Assessment Fees for
Read more

KC EMC | Changes to KC ID Applicant Codes

-
Image
  As of July 24, 2024, the applicant identification codes for the KC ID in electromagnetic certification have been updated. These codes, previously fixed at 3 digits, have been modified to accommodate both 3 and 4-digit formats. To ensure uniqueness, each applicant code must be assigned without duplicating any existing codes and must be composed exclusively of a combination of letters and numbers. 👉 Contact GCA Tel. +82-31-360-8180 Email: forest.lee@gca-kr.com GCA Global Website
Read more