Global Regulatory Press

21/01/2025

19/11/2024

*Out now in the JMDR Digital Bookstore*:

Learn all bout the Korean regulatory framework for medical devices in

‘An overview of the regulatory requirements for medical devices in the Republic of Korea’

11/11/2024

You can purchase this and other articles from the current JMDR November 2024 issue in our Digital Bookstore: https://globalregulatorypress.com/product/interview-katherine-wang-talks-to-the-jmdr-about-chinas-draft-medical-device-administrative-law

22/10/2024

*Sneak Preview JMDR November 2024 issue*:
⚡️An overview of the regulatory requirements for medical devices in the Republic of Korea
The Ministry of Food and Drug Safety (MFDS) is responsible for medical device regulation in the Republic of Korea. It oversees the evaluation, classification, registration, and licensing of all medical devices, and is also responsible for reviewing and approving applications for the manufacture or importation of medical devices and equipment.
In 2003, the MFDS introduced the Medical Device Act and established a risk-based medical device classification system. The MFDS also introduced a requirement for a Quality Management System for medical devices in 2004 and established requirements for clinical trials of medical devices in 2005.

This article clarifies the definition of a medical device, the classification of medical devices, the requirement for a local distributor/agent/Authorised Representative, and the requirement for a business licence. The article also outlines the general Korean Good Manufacturing Practice (KGMP) medical device registration route, pre-market notification for Class I devices, pre-market certification for substantially equivalent Class II devices, and pre-market approval for not substantially equivalent Class II devices, and Class III/Class IV devices. It also addresses the quality system requirements/KGMP/inspections, post-market requirements, and labelling requirements.

16/10/2024

*Sneak Preview: In the upcoming JMDR November 2024 issue*:

Unlock insights on China’s regulatory landscape in our exclusive interview with
‘Katherine Wang on the important new draft ‘Medical Device Administrative Law

14/10/2024

*Sneak Preview: In the upcoming JMDR November 2024* issue:

Discover key insights and actionable guidance in

‘An Analysis of the EU MDCG Recommendations on Clinical Investigation Plans and Investigator’s Brochures’

28/08/2024

*Regulatory News from Thailand: Have you heard about the simplified registration process for medical devices?
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22/08/2024

*Regulatory News from Israel:

🚀Fast-track registration process launched for class II devices and medium risk IVDs

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