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JNM Global/Medical Device 121

Hong Kong MDD, Updated the Guidance (GN-01) on Renewal Application for Listing Medical Device

The Hong Kong Medical Device Division (MDD) has implemented the Medical Device Administrative Control System (MDACS) to regulate medical devices, including operating a device registration system and an adverse event reporting system.  On September 30, 2024, the MDD updated Sections 5.14 and 5.15 in the Guidance (GN-01) on the Overview of the Medical Device Administrative Control System (MDACS), ..

Thai FDA, Update on The Guideline for the Transfer of Medical Device License

When a holder of a manufacturing or import license for a medical device wishes to transfer the license to another company, the transfer of the license may be required.  The Thai Food and Drug Administration (TFDA) updated the guidelines for the transfer of medical device licenses for manufacturer and importers on September 19, 2024.  For medical devices that do not require expert review for appr..

Korea MFDS, Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Officials) Revised

As of October 11, 2024, the Ministry of Food and Drug Safety has registered the revised version of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials). The revised contents of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials) are briefly as follows. 1. R..

Japan PMDA, List of Third-Party Registered Certification Bodies (RCBs)

PMDA (Pharmaceutical and Medical Device Agency) is a comprehensive pharmaceutical and medical device organization that aims to contribute to improving national health by guiding and examining the quality, efficacy, and safety of pharmaceuticals and medical devices, and collecting, analyzing, and providing information on safety after marketing. Japan's medical device classification system is base..

Thailand FDA, Update on Labeling Guidelines for in Vitro Diagnostic Medical Devices (IVD)

On October 7, 2024, the Thailand Food and Drug Administration (TFDA) announced new guidelines regarding labeling requirements for In Vitro Diagnostic Medical Devices (IVD). These guidelines clarify labeling methods for both home-use and professional-use IVDs, with key points outlined below.  1.   Labeling Requirements for Home-Use- Labels must be affixed in clearly readable Thai and English (pro..

Indonesia MoH, Announces Requirements for E-Katalog System Regarding Application of Medical Device GDP Certificate

The Ministry of Health (MoH) of Republic of Indonesia issued circular no. HK.02.02/E/1753/2024 on September 9, 2024, to implement the Good Distribution Practice (GDP) certification as a requirement for the electronic catalog system, ensuring the safety, quality, and performance of medical devices.According to Government Regulation No. 28 of 2024 (implementing Law No. 17 of 2023 on Health), the k..

EU EC MDCG, Releases New Guidance on Qualification of in vitro diagnostic medical devices(IVDs

On October 8, 2024, the European Commission’s Medical Device Coordination Group (MDCG) announced guidance MDCG 2024-11 regarding the qualification of in vitro diagnostic medical devices (IVDs). To achieve qualification as an IVD or an accessory, a product must meet the criteria defined in Article 2(2) or Article 2(4) of the IVDR. The MDCG 2024-11 guidance clarifies the scope of products covered ..

Korea MFDS, Partial Revision of the Enforcement Regulations of the Medical Devices Act (Prime Minister's Decree No. 1982)

The Ministry of Food and Drug Safety announced a partial revision of the “Enforcement Regulations of the Medical Device Act” (Prime Minister’s Decree No. 1982) on September 20, 2024. The contents of the Partial Amendment Decree of the “Enforcement Regulations of the Medical Devices Act” (Prime Minister’s Decree No. 1982) are briefly as follows. : Improvement and supplementation of deficiencies i..

Vietnam IMDA, Introduction of Guidance for Updating Documents of Medical Device Registration Facilities

On August 16, 2024, Vietnam introduced new guidance allowing the update of specific documents related to medical device registration facilities on the IMDA website during the regulatory review process.  This guidance permits updates for two types of documents related to changes in registration facilities. 1. Updating documents related to changes in registration facility information      - When c..

Vietnam IMDA, Online Public Service System Domain Changed from DMEC to IMDA

Vietnam's Ministry of Health announced on August 30, 2024 regarding the domain change of the online public service system for medical device management. Vietnam's Ministry of Health changes the domain of the online public service system for medical device management as follows. - Domain before change (DMEC): https://dmec.moh.gov.vn- Domain after change (IMDA): https://imda.moh.gov.vn From Septem..