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..

The FDA has implemented the Voluntary Cosmetic Registration Program (VCRP) for general cosmetics, but the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022 for the safety of consumers.Under MOCRA, manufacturers who manufacture or process cosmetics distributed in the United States are required to prepare safety reports, labeling requirements, and register ..

Thailand's Ministry of Health issued a notice affecting medical device manufacturing and marketing authorization on June 20, 2024, and the contents are as follows. 1.     Manufacturing ControllersAll establishments, license holders, or notified entities must appoint at least one manufacturing controller with the following qualifications and duties Qualifications and Duties >- A bachelor’s degree..

The FDA published a revised MDSAP AUDIT APPROACH (MDSAP AU P0002.009) on August 6, 2024.The revision from MDSAP AU P0002.008 to 009 is briefly as follows. 1. Australia (TGA)As a result of changes to the Guidance for Australia (TGA) country-specific requirements, the following items have been revised or removed from the TGA requirements.1) Management - Task 5 & Task 82) Device Marketing Authoriza..