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..

The National Medical Products Administration (NMPA) of China issued the Regulations on July 8, 2024 to steadily promote the relevant work of high-frequency treatment devices and high-frequency skin treatment devices, and take into account the requirements of public equipment safety and orderly development of the industry. Annex 09-07-02 of the “Notice on Partial Adjustment of the Medical Device ..

The Australian Therapeutic Goods Administration (TGA) has updated its medical device distribution record requirements from 23 May 2024. Under section 41FO of the Treatment Supplies Act 1989, sponsors of medical devices supplied and exported from Australia must keep the following distribution record.Expedite any recalls of the medical devices.Identify the manufacturer of each batch of devices.Rec..

In Australia, sunscreen is classified as a primary sunscreen or a secondary sunscreen depending on the SPF index. If it is classified as a medical product according to the performance of sunscreen, it is subject to TGA regulation, and if it is classified as a cosmetic, it is subject to AICIS regulation. Australia's Therapeutic Goods Administration (TGA) has announced updated requirements for sun..