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..

The FDA receives more than 2 million medical device reports (MDRs) annually related to deaths, serious injuries, and malfunctions of medica devices. Especially malfunction reports represent most of the MDRs received each year.  On August 28, 2024, the FDA announced final guidance for the Voluntary Malfunction Summary Reporting (VMSR) program for manufacturers. The VMSR program simplifies the rep..

The Ministry of Food and Drug Safety (MFDS) has strengthened the labeling obligations on containers and packaging for certain cosmetics with small amounts of contents through the update of the “Enforcement Rule of the Cosmetics Act” Accordingly, on September 24, 2024, the MFDS newly established types of cosmetics with small volumes or weights that require labeling of precautions for use, and it ..

The De Novo classification is an FDA regulatory mechanism used for new medical devices that are anticipated to be Class I or Class II with low risk when there is no suitable predicate device to claim substantial equivalence. The FDA announced the final guidance on the electronic submission template for De Novo (FDA-2023-D-3788) on August 23, 2024. This guidance includes on the use of the electro..

Taiwan TFDA announced on June 30, 2024 that it is implementing Good Manufacturing Practice (GMP) to ensure the quality of cosmetics, and GMP for cosmetics will be officially implemented from July 1, 2024. The manufacturing sites for sunscreens, hair dyes, perm products, antiperspirants, deodorants, and home-use teeth whitening products containing peroxide will be the first group required to comp..

Two new features related to product listing have been updated in the Cosmetic Direct Portal, the U.S. FDA’s electronic submission portal for MOCRA cosmetic facility registration and product listing. These updates will enhance the convenience of product management.  The two new features added to the Cosmetic Direct Portal are as follows:- Products discontinued in the market can now be marked as d..

swissdamed is the new Swissmedic database for registering economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market. The new medical devices platform "swissdamed" will be introduced gradually from 6 August 2024. swissdamed is being rolled out in phases. The first release of the "Actors" module enables economic operators to register online. Economi..

UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a consultation to seek views from interested stakeholders on proposals to update its statutory fees.  MHRA consultation on statutory fees - proposals on ongoing cost recovery are as follows. 1) Proposal 1 The MHRA proposes to increase the statutory fees shown in Annex B to ensure c..