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..

According to the announcement made by the UK OPSS on October 14, 2024, all cosmetics containing the banned ingredient “Lilial” must be discarded, and the recall of products sold after the ban is being considered.  Lilial(Butylphenyl methylpropional), a fragrance ingredient that provides a lily scent, has been used in shampoos, perfumes, and body products, etc. However, it is known to raise safet..

Health Canada (HC) published amendments to certain regulations concerning the disclosure of cosmetic ingredients (SOR/2024-63) on April 24, 2024, which came into effect on October 9.  This includes adjustments to regulatory requirements that may impact all stakeholders in the cosmetic industry, making it essential to review the updated regulations.  The amended regulations strengthen labeling re..

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..