China, the National Medical Products Administration (NMPA), announced the on April 29, 2024, to strengthen supervision and standardize the inspection of cosmetics and implemented it on November 1, 2024. The key points of the Cosmetics Inspection and Management Methods are as follows: 1) Inspection Subjects:- Cosmetics manufacturers, operators, and other relevant entities and individuals subject..

On November 4, 2024, China’s National Medical Products Administration (NMPA) approved the registration of a new cosmetic ingredient, Isobutylamido Thiazoyl Resorcinol (Thiamidol 630).  This ingredient is the first to be registered since the implementation of the Cosmetics Supervision and Administration Regulation (CSAR) in 2021. It has been verified for its efficacy and safety by the registratio..

On October 30, 2024, the National Medical Products Administration (NMPA) of China updated the Safety and Technical Standards for Cosmetics (2015). The update includes the addition of five testing methods, one of which is for the “Test Methods for Azelaic Acid and its Salts in cosmetics”These new and revised standards are now incorporated into the 2015 edition of the Safety and Technical Standard..

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 ..

NMPA announced “notice on improving cosmetics safety evaluation and management measures” on April 22, 2024 to further optimize cosmetics safety evaluation and management and to promote orderly implementation of the cosmetics safety evaluation system. This announcement will take effect from May 1, 2024. The contents of the notice, which will take effect from May 1, 2024, are as follows. 1. Classi..

The CMDE under the National Medical Products Administration (NMPA) of China has issued guidelines for registration and review of high-frequency beauty devices (No. 8[2023]). Manufacturers of radio frequency beauty devices classified as Class III will have to comply with the new technical review guidelines from April 1, 2024. The High Frequency beauty device Registration and Review Guidelines (No..

On February 17, 2023, the NMPA in China made an announcement on the implementation of the 3rd Unique Device Identification (UDI) of medical devices. Depending on the degree of risk and regulatory needs, some Class2 medical devices, such as disposable products with high clinical demand, products selected for mass supply, and medical beauty-related products, are determined to be in the third batch..

China medical industry is still growing rapidly. As of 2022, the Chinese medical device market was 1.3 trillion yuan, growing 6.1 in size compared to 2013. The Chinese medical device market has a global market share of 27.5%, with an average annual growth rate of more than 12% over the past five years. China is a market that cannot be abandoned despite its policy of using domestic medical device..

China's National Medicines Agency (NMPA) has announced amendments to its catalog to classify medical devices. Manufacturers need a lot of attention because the amendment affects the cost and time of medical device registration. The 56 changes announced include adding new products, changing descriptions of some devices, and changing some device classifications. We inform you of the major revision..

中国国家医療製品管理国(NMPA)と医療機器評価(CMDE)は、医療機器の安全を実装する企業の監督及び管理に対する新しい規則と植え込み式医療機器バッテリーの登録及び検討に対する指針の草案を発表しました。 2022年告示第124号 2022年11月草案協議後NMPAは、2023年3月1日から施行される医療機器品質及び安全に対する主要の責任を履行する企業の監督及び管理に関する規定の発行を発表しました。このため、登録者と記録ファイラーが医療機器品質及び安全に対する主要責任を履行する必要があります。 また、医療機器の生産及び運営企業から品質及び安全の主要職責を受ける医療機器の登録者、ファイラー、委託製造業者及び直員に対する責任履行を強調する条項も含まれております。 医療機器の品質及び安全に対する主要責任を履行する企業の監督及び管理に関する規定の解釈は、追加でより詳しく協議されます。 植え込み式..