Indonesia BPOM, Release Draft Regulation on Class B Cosmetic Production Scope

On November 2, 2026, the National Agency for Drug and Food Control of Indonesia(BPOM) has released a draft regulation concerning the types of cosmetic products that can be manufactured by Class B cosmetic manufacturers. The draft will replace the existing Regulation No. 8 of 2021 of BPOM on the Dosage Forms and Preparation Types of Certain Cosmetics That Can Be Produced by Cosmetic Manufacturers..

Korea MFDS, Revision of Guidelines for Cybersecurity Authorization and Review of Medical Devices

On October 30, 2026, the Ministry of Food and Drug Safety (MFDS) of South Korea has revised its "Guideline on Cybersecurity for Medical Devices" to align requirements for authentication information and passwords with international regulatory standards, while also providing more specific details on items frequently flagged during the review process. The details are as follow:- Ensure that authent..

On October 22, 2026, the Ministry of Food and Drug Safety (MFDS) of South Korea has prepared a revised draft of the "Guidelines for Submitting Reports on Functional Cosmetics Exempt from Review," which includes guidance on verifying requirements when preparing such reports, as well as improvements to the reporting system for customized cosmetics. This draft revision mainly adds an explanation of..

On October 29, 2026, the Ministry of Food and Drug Safety (MFDS) of South Korea has announced a proposed amendment to the *Regulations on the Approval, Notification, and Review of In Vitro Diagnostic Medical Devices*. The objective of this amendment is to improve and rationalize the approval and review system for in vitro diagnostic (IVD) medical devices. Key changes include: (1) allowing clinic..

On October 8, 2026, China’s National Medical Products Administration (NMPA) has issued an amendment to the announcement regarding the implementation of safety and technical standards for cosmetic products. The key changes are as follows:1. Revisions regarding prohibited, restricted, and permitted ingredients- For products registered or submitted prior to these revisions, if adjustments to the fo..

On October 12, 2026, the Philippine Food and Drug Administration (FDA) has proposed a draft circular to adopt Good Manufacturing Practice (GMP) guidelines for medical devices, in accordance with the Philippine National Standard (PNS) ISO 13485:2019. The draft circular applies to all local manufacturers of medical devices—including in vitro diagnostic (IVD) medical devices—and also encompasses ot..

On October 2, 2026, Vietnam’s Ministry of Health(MoH) notified the World Trade Organization (WTO) of a draft Decree on the Management of Cosmetics. This comprehensive draft, consisting of 10 chapters and 60 articles, introduces significant changes to the regulatory framework governing the production, notification, import, export, and circulation of cosmetics in Vietnam.Compared with the current ..

On September 24, 2026, the Brazilian National Health Surveillance Agency (ANVISA) proposed Public Consultation No. 1423 regarding the classification and registration of single-use and reusable medical devices. The purpose of this proposal is to establish new regulations setting forth the requirements for classifying and registering medical devices as single-use or reusable, including labeling an..

On October 8, 2026, China’s National Medical Products Administration (NMPA) issued the Announcement on Matters Concerning the Implementation of the Revised Contents of the Safety and Technical Standards (STSC) for Comsetics. Addressing the catalogs of prohibited/restricted and permitted ingredients of cosmetics (including toothpaste), the microbiological and harmful substance limits, and the tes..

On September 30, 2026, Malaysia’s Medical Device Authority(MDA) issued an announcement introducing a defined validity period for Product Classification Letters, along with changes to how classification applications are submitted and processed. The changes took effect on October 1, 2026. Product Classification Letters are issued through MDA’s Product Classification Application System(PCAS) and ar..