MFDS Approves 145 Medical Products in April 2025

-

The Ministry of Food and Drug Safety (MFDS) approved 145 medical products in April 2025, including:

  •  39 pharmaceutical products
  •  5 quasi-drugs
  •  101 medical devices

These figures are based on approvals granted by the MFDS headquarters, excluding those processed by local regional offices. Compared to the monthly average of 124 approvals in 2024, this represents 116.9%, and compared to the first-quarter monthly average of 110 approvals in 2025, it amounts to 131.8% — indicating a noticeable upward trend.



⚡Your Shortcut to Medical Device Approval in Korea – GCA KOREA!
From documentation to regulatory consulting – we guide you every step of the way.


Contact us today

※ Unauthorized reproduction, citation, or use of this content is prohibited. The source and link must be clearly stated.


👉 Contact GCA

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

Comments

Post a Comment

Popular posts from this blog

South Korea Mandates Fire Extinguishers in All Vehicles with Five or More Seats

-
Image
  Vehicle fire extinguisher Starting December 1, 2024, all vehicles with five or more seats must be equipped with a "vehicle-compatible" fire extinguisher. This regulation follows the amendment to the Fire Facilities Installation and Management Act, which expands the requirement for installing fire extinguishers in vehicles. Applicable Vehicles • Vehicles manufactured, imported, or sold after December 1 • Vehicles newly registered under Article 6 of the Motor Vehicle Management Act due to a change in ownership Note: This regulation does not apply retroactively to vehicles already registered. Verification of Fire Extinguisher Installation in Vehicles Compliance with the fire extinguisher installation requirement will be checked during vehicle inspections conducted under the Motor Vehicle Management Act. Requirements for Vehicle Fire Extinguishers This refers to a fire extinguisher that has not only passed the performance tests for general powder fire extinguishers but has also...
Read more

Upcoming Changes to Child Car Seat Safety Standards in Korea

-
Image
  To enhance child safety and align with global regulations, Korea is preparing to revise the safety standards for child restraint systems (car seats). Here’s what you need to know Why Are These Changes Happening? Child car seats are essential for protecting children during car accidents. Recognizing the risks, Korea is taking steps to strengthen safety requirements, ensuring better protection for young passengers. What’s Changing? 1. Updated Standards: The current standard (UN/ECE/R44) will be replaced by the enhanced international standard (UN/ECE/R129). 2. New Safety Requirements: The revised standards will include test conditions for two-point retractable seat belts, improving overall safety measures. When Do These Changes Take Effect? Start Date: January 1, 2025 Transition Period: Until December 31, 2026, the previous standards in Annex 3 can still be applied alongside the new ones. Preparing for the Transition Manufacturers and exporters must align with the updated regulation...
Read more

KCs Ex Certification | Essential Explosion-Proof Safety for Industries

-
Image
  KCs Ex Certification for explosion proof products What is KCs Ex Certification? Essential Safety for Explosion-Proof Products KCs Ex Certification is a Korean explosion-proof safety certification system that ensures electrical machines and devices used in industrial environments with explosion hazards meet strict safety standards. This certification is crucial for the safe use of products in explosive environments and helps protect the safety of workers. Why is KCs Ex Explosion-Proof Certification Necessary? 1. Ensuring Safety In environments with explosive gases, dust, or other hazardous substances, even a small spark can lead to an explosion. KCs Ex Certification minimizes these risks by ensuring products are designed to prevent accidents, thus safeguarding workers' safety. 2. Legal Requirement Under the Korean Industrial Safety and Health Act, electrical machines and equipment with explosion-proof structures must obtain KCs Ex Certification. This is a mandatory requirement to...
Read more