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..

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 ..

The UK Office for Product Safety and Standards (OPSS) has requested the disposal of all cosmetics containing the prohibited ingredient "Lilial" (Butylephenyl methylpropional) on October 14, 2024. This ingredient is known to be harmful to the reproductive system and was added to Annex 2 of the Toys and Cosmetics (Prohibited Substances) Regulations in 2022, prohibiting the sale of products contain..

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..

On September 18, 2024, the Indonesian Food and Drug Authority (BPOM) announced new regulations to replace regulations on contamination limits in cosmetics established in 2019. The updated regulations regarding contamination limits in cosmetics include the following additions: The introduction of contamination limits for acrylamide and diethylene glycol regarding chemical contamination in cosmeti..

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'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..

The FDA receives more than 2 million medical device reports (MDRs) annually related to deaths, serious injuries, and malfunctions of medica devices. Especially malfunction reports represent most of the MDRs received each year.  On August 28, 2024, the FDA announced final guidance for the Voluntary Malfunction Summary Reporting (VMSR) program for manufacturers. The VMSR program simplifies the rep..

The Ministry of Food and Drug Safety (MFDS) has strengthened the labeling obligations on containers and packaging for certain cosmetics with small amounts of contents through the update of the “Enforcement Rule of the Cosmetics Act” Accordingly, on September 24, 2024, the MFDS newly established types of cosmetics with small volumes or weights that require labeling of precautions for use, and it ..

The De Novo classification is an FDA regulatory mechanism used for new medical devices that are anticipated to be Class I or Class II with low risk when there is no suitable predicate device to claim substantial equivalence. The FDA announced the final guidance on the electronic submission template for De Novo (FDA-2023-D-3788) on August 23, 2024. This guidance includes on the use of the electro..