Saudi Arabia SFDA, Announcement of Guidance on ISO 13485 Requirements and Corresponding SFDA-MDS Requirements

On March 25, 2025, a guidance document was issued to provide compliance instructions on ISO 13485:2016 Medical Devices-Quality Management System-Requirements (ISO 13485) for medical device manufacturers, authorized representatives, importers, and distributors, considering the regulatory documents issued by the Saudi Food and Drug Authority (SFDA) Medical Devices Sector (MDS).  Manufacturers, imp..

UK SCPN, Announcement of restrictions on the use of Methyl salicylate hydroxybenzoate in Cosmetics

On March 31, 2025, the United Kingdom issued the final draft of the Cosmetics (Chemical Restrictions) Regulation 2025 to impose restrictions on the use of Methyl salicylate hydroxybenzoate (CAS No. 119-36-8). This substance is classified as a Category CMR (2) substance under the EU Regulation (EC) No. 1272/2008 on classification, labeling, and packaging. As a result, the item for Methyl Salicyla..

Following the amendment of the Cosmetics Act on January 31, 2025, which abolished government certification for natural and organic cosmetics, the Ministry of Food and Drug Safety (MFDS) announced a draft notice on March 26, 2025, regarding the repeal of the Regulation on Standards for Natural and Organic Cosmetics and the Regulation on the Designation and Certification of Certification Bodies fo..

To import, distribute, and supply medical devices in the Malaysia market, compliance with the requirements of the Medical Device Act 2012 (Act 737), including medical device registration, is required.  However, if medical devices need to be imported and re-exported for purposes such as maintenance, testing, sterilization, packaging, labeling, distribution hurbs, or other purposes designated by t..

On February 26, 2025, Brazil’s ANVISA announced an amended resolution, Resolution RDC No. 966 (2025), which postpones the effective date of the updated product classification rules for cosmetics under Resolution RDC No. 949 (2024).For details on the updated cosmetic product classification, please refer to the previously posted link below.https://blog.naver.com/PostView.naver?blogId=jnm-ko-rea&lo..

On February 27, 2025, the French government enacted and promulgated legislation regulating per-and polyfluoroalkyl substances (PFAS) in certain products – such as cosmetics, wax-based products, and textile clothing – in order to prevent risks associated with PFAS exposure and to protect public health and the environment.  PFAS are chemical substances commonly used in various products such as foo..

On March 11, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a public notice regarding the partial revision of the standards for medical device manufacturing and quality control. This revision aims to allow domestic export companies to undergo both KGMP and Medical Device Single Audit Program (MDSAP) simultaneously.  The revision provides a legal basis for combining the ‘MDS..

On February 28, 2025, the Enforcement Rule of the Digital Medical Products Act was established to define the delegated matters and necessary implementation details following the enactment of the Digital Medical Products Act (effective January 24, 2025) and its Enforcement Decree (effective January 24, 2025).The key provisions of the Enforcement Rule include:1) Specific criteria for the classific..

On February 3, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced new guidance on Digital Mental Health Technologies (DMHT) due to the increasing use of mental health apps, AI-based assessments, virtual reality therapies, and other digital mental health technologies. This new guidance is aimed at manufacturers.  The guidance document helps manufacturers identify th..

The Cosmetic Ingredient Hotlist is an administrative tool by Health Canada (HC) that informs manufacturers and other stakeholders about substances that may be prohibited or restricted in cosmetic products. This document is periodically reviewed and updated.  In February 2025, HC updated and published the Cosmetic Ingredient Hotlist. The key updates are as follows: * Added Items 1) Retinal: Restr..