Regulatory News from Across Asia-Pacific

China’s NMPA reported 7 cases of cosmetic regulatory violations on November 20, 2023 to ensure manufacturer meet compliance with regulations.

CMDE has been exploring the use of Real-World Evidence to support clinical evaluation since 2018 and is of increasing importance.

China’s NMPA has released draft guidelines for writing medical device IFU and seek for Industry stakeholders' comment until December 1, 2023.

China’s NIFDC has reopened the Cosmetic Ingredient Code Submission platform to compound ingredients as of November 1, 2023.

Breakfast seminar on health technology in Hong Kong and GBA will be carried out on November 27, 2023, at the Finland Chamber of Commerce.

China motor vehicle and trailers have newly revised CCC certification rules announced by the CCAP on October 12, 2023.

Medical devices urgently needed for clinical use in China have new draft requirements announced by the CMDE for temporary importation.

China medical device sampling inspection results have recently been announced by the NMPA on September 28, 2023

China toothpaste simplified notification information released by NMPA and toothpaste products are marketed in China.

China medical device master filing aims to protect confidential information from being disclosed during the NMPA registration process

China’s NMPA has released draft Measures for Cosmetic Inspection which are now open for industry comment until

Cosmetic Ingredient Safety Information Annex 14 Technical Guidelines have been issued by NIFDC to help registrants complete information.

Hong Kong new drug application, fulfilling the conditional requirements, will require one overseas marketing approvals instead of two.

China issues guidelines for cosmetics raw materials manufacturers on how to complete the cosmetic ingredient safety information platform.

China launches an Expert Consultation Mechanism to solve interpretation issues of the updated GB9706 Medical Electrical Equipment Standards.

China electric bicycle certification has new CCC rules to adhere to, as per CNCA's official announcement on September 14, 2023.

China recycling batteries for new energy vehicles has new certification rules announced by the CNCA for implementation on September 25, 2023.

Human factors design for medical devices in China has draft guidelines revised and issued by the CMDE on October 10, 2023.

Acclime and Cisema jointly analyse and present the latest developments and trends for medical device registration and distribution in China.

Filing for cosmetic formulas in China has new technical guidelines issued by the NIFDC on September 4, 2023.