Indonesia BPOM, Draft Announcement of the Amendment to the Regulation on the Service Standards of OTSKK (Evaluation of Cosmetic Safety, Quality, and Efficacy)

In order to distribute cosmetics in Indonesia, products must be registered or notified with the Indonesian National Agency of Drug and Food Control (BPOM). For certain products that contain new ingredients or are classified as new products, an evaluation by the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics (OTSKK) is required. On April 9, 2025, the D..

Mexico COFEPRIS, Announcement of the Revised Good Manufacturing Practices (GMP) for Medical devices

On April 4, 2025, Mexico’s COFEPRIS announced the revised version of the Good Manufacturing Practices for medical devices (NOM-241-SSA1-2025). This standard establishes the minimum requirements for the design, development, manufacturing, storage, and distribution processes of medical devices. For medical device registration, the submission of GMP certification documents is required for devices ..

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..