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 ..

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The U.S. Food and Drug Administration published a draft guidance document on March 13, 2024, of Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. FDA intends to incorporate the updates proposed in this draft guidance into the Premarket Cybersecurity Guidance as one final guidance document after obtaining and considering public comment on these proposed select..

FDA published a Quality Management System Regulation (QMSR) final rule on February 2, 2024 to revise the current good manufacturing practice (CGMP) requirements for medical devices in the Quality System (QS) Regulation (21 CFR Part 820). FDA amends Part 820 to incorporate the QMS requirements of ISO13485 as references. Replacing the Quality System(QS) with the Quality Management System Regulatio..

The U.S. FDA was scheduled to open a platform in October to register and list cosmetics facilities required by the U.S. Cosmetics Regulatory Modernization Act (MoCRA). Therefore, the existing products sold had to be listed by December 29, 2023. However, there were many opinions from global companies and related organizations that they needed time to prepare for regulatory response. The FDA accep..

The Cosmetics Regulation Modernization Act (MoCRA) is important to the chapter VI of the Federal Food, Drugs and Cosmetics Act (FDCA) and adds new information (GMP, safety proof, critical adverse event reporting, facility registration, product registration, additional labeling marks, record keeping, etc.). It also gives the FDA the authority to order compulsory recalls. MoCRA's facility registra..

To enter the Thai beauty market, it is essential to register cosmetics with the Thai FDA. Thai cosmetics are regulated under Cosmetics Act BB.E 2558(2015). Also, Thai cosmetics are regulated by ASEAN Cosmetic Directive(ACD) under the guidelines of ASEAN Cosmetic Committee(ACC). When registering cosmetics, PIF and label are basically required. - Material safety data sheet (MFDS) - GMP or ISO of m..

MoCRA（Modernization of Cosmetics regulation Act of 2022）により今年3月からVCRPプログラムが中断されました。 2023年8月7日、FDAは化粧品施設登録及び製品搭載に対する草案を発表しました。 MoCRAによると、既存の化粧品施設及び製品に対する情報は今年の12月29日までに提出する必要があり、2年ごとに更新する必要があるとのことです。 またFDAに施設登録及び製品の搭載に費用は不要となります。 下記の通り施設の登録及び製品の搭載に対する説明をさせていただきます。 １）施設の登録：化粧品の製造業者に対する情報を提出し、FEI（FDA Establoshment Identifier）施設登録番号に管理されます。 ２）製品搭載：製品に対する成分、ラベルに対する情報を提出し、2023年10月から電子提出ポータルを使用することができま..

The VCRP program has been suspended since March this year under the Modernization of Cosmetics Regulation Act of 2022. On August 7, 2023, the FDA issues draft guidance for registration and listing of cosmetic product facilities and product Under MoCRA, submission of information about existing cosmetic product facilities and products is required no later than Dec. 29 and Renewal every two years. ..

The label of the medical device should be marked on the container, exterior, or external packaging. It should be in a location where consumers can easily find it, and should not fall off easily. Medical device labels are mandatory, and each country has its own obligations. We will briefly explain the labeling requirements in Korea, the US and Europe. 1. Korea (1) Trade name and address of manufa..