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..

2020年1月中国产业信息技术部发布的55项标准于2020年7月1日起生效， 其中的55个标准中，与针织衣相关的新开发及修改的标准如下: • FZ/T 73020-2019 “Knitted Casual Wear” • FZ/T 73022-2019 “Knitted Thermal Underwear” • FZ/T 73025-2019 “Knitted Garments and Accessories for Infants” FZ/T 73020-2019"Knitted Casual Wear"指定了针织休闲服装、产品类型、测试方法、抽样规则、产品指南、包装、运输及保管的用语及定义，主要变更事项如下: • 用语及定义 : definition of mini shorts and fluorescent colors was added • 关于产品尺寸的标签规则 • 物质..

Um die Verantwortung der Marktteilnehmer zu stärken und das wirtschaftliche Umfeld zu optimieren, hat CNCA die Ankündigung #44 im Jahr 2019 veröffentlicht. Nach dieser Ankündigung wurden 18 Arten von Produkten von den erforderlichen Zertifizierungsverfahren ausgeschlossen, und es gibt zwei Hauptkategorien : 1. Audio- und Videoausrüstung, d. h. Empfänger und Radio-Tuning für verschiedene Rundfunk..

Alle Produkte, die in den Bereich der chinesischen Zwangszertifizierung (CCC) fallen, müssen CCC-Tests und Fabrikinspektionen durch die Verwaltungsstelle, die von CNCA benannt ist, durchgeführt werden. Spielzeugprodukte, die in den Anwendungsbereich des CCC fallen, sind in 22 Kategorien, und 159 Arten von Produkten müssen die CCC-Konformitätsanforderungen erfüllen, bevor sie in China verkauft, i..