South Korea to Mandate ‘Use-By Period After Opening’ on Blood Glucose Test Strip Packaging

-

On July 28, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced the reissue of a partial amendment to the Enforcement Rule of the In Vitro Diagnostic Medical Devices Act. The amendment aims to improve the quality and infrastructure of newly developed in vitro diagnostic medical devices (IVDs) and address gaps in the current system.


Key Changes

  • Approval fees for new IVDs will be revised, with provisions for fee reductions.
  • Applicants for manufacturing licenses or modifications will be exempt from resubmitting verified quality manager qualification documents.
  • Packaging of personal blood glucose test strips must indicate the period of use after opening.
  • The Class I IVD management system will move to a notification-based process with a five-day processing period.


Institutions, organizations, and individuals may submit opinions on the amendment online or by sending a written statement to MFDS by September 8, 2025.


For inquiries about South Korea’s regulations on in vitro diagnostic medical devices, please contact GCA KOREA. As a trusted partner for KC certification and IVD regulatory compliance, we are committed to supporting your successful market entry. For the latest updates on Korea’s Medical Devices Act, including recent proposed revisions, please visit our official website.



Contact ⬇

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

Comments

Post a Comment

Popular posts from this blog

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

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

KCs Ex Certification | Compatibility with IECEx and ATEX

-
Image
  KCs Ex Certification for explosion proof products KCs Ex Certification and Its Compatibility with IECEx and ATEX The IECEx and ATEX international explosion-proof certification systems are globally recognized, and KCs Ex certification is also mutually compatible with these international certifications. Thanks to this compatibility, global companies can easily certify and sell the same product in multiple countries. However, even if a product has already obtained IECEx or ATEX certification, it must still acquire KCs Ex certification to be sold or installed in Korea. During the KCs Ex certification process, some testing and documentation requirements may be waived or simplified. Challenges and Solutions for Obtaining KCs Ex Certification The process of obtaining KCs Ex certification in Korea can be challenging due to complex procedures and extensive documentation requirements. However, with GCA KOREA, you can avoid these complexities and proceed with the certification process quic...
Read more