In Canada, all manufacturers and importers are required to notify Health Canada (HC) within 10 days of first selling a cosmetic product. Failure to submit the notification within the deadline may result in import refusal or suspension of sales. In March 2025, HC updated the Cosmetic Notification Form (CNF). As of March 5, 2025, Section 4 of the updated form requires manufacturers or importers t..

In Malaysia, the classification of medical device must be carried out by the manufacturer in accordance with the prescribed manner, based on the level of risk, intended use, and the vulnerability of the human body as stated in Section 3(1) of Act 737. In the event of a dispute between the manufacturer and the Conformity Assessment Body(CAB) regarding the classification of a medical device, the m..

On March 18, 2025, the Philippine Food and Drug Administration (FDA) issued FDA Circular No. 2025-002, announcing updates and amendments to the ASEAN Cosmetic Directive (ACD). The directive provides information on the list of substances that must not be included in cosmetic products, as well as the lists of permitted preservatives and allowed UV filters that may be used in cosmetics. Updates an..

On March 24, 2025, Australia’s Unique Device Identification (UDI) regulatory framework came into effect to enhance patient safety and improve the efficiency of the regulatory system, including the management of post-market safety activities such as recalls. In line with this, the Therapeutic Goods Administration (TGA) released guidance on UDI requirements and compliance with identification timel..

On March 10, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced a regulatory revision regarding the special labeling of specific ingredients in cosmetics. Through this notification, the long-standing regulation in place since 1985 has been repealed, and the rules concerning the labeling and advertising of specific cosmetic ingredients have been revised.  The key points of the ..

On Mar 18, 2025, the European Commission (EC) published the revised guidance on classification rules for In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746, under MDCG 2020-16 rev.4.  The purpose of this document is to provide guidance to manufacturers, Notified Bodies (NB), and healthcare institutions on how to classify In Vitro Diagnostic Medical Devices before placing them on..

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..

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..