Regulatory News from Across Asia-Pacific

This is an important guidance in the framework of the new cosmetics regulations that came into force at the start of 2021.

The China NMPA technical guidelines for cosmetic safety assessment (2021 Edition) will come into effect from May 1, 2021, onwards.

The NMPA announced various measures for cosmetic registration and filing information management to support the implementation of the CSAR.

9 product categories have been reported by the NMPA for not meeting the standard requirements whilst 12 regulatory guidelines and drafts have been issued.

According to the announcement published by the Centre for Medical Device Evaluation) of the National Medical Products Administration on April 12, 2021...

The announcement cover details of the working procedures and appendices for quality spot checks and inspection procedures for medical devices within China.

Inspection work shall be carried out in accordance with the mandatory standards or product technical requirements for post-market activities in China.

The Guangdong MPA announced the first approved medical device arriving the University of Hong Kong – Shenzhen Hospital via the Greater Bay Area initiative.

The SAMR published new technical requirements to expand the scope of health food in dosage forms and excipients for filing, with effect from June 1 onwards.

The NMPA announced 2 new Provisions to support the implementation of the CSAR, and the exemption of animal testing for general cosmetics.

On March 2, 2021, the NMPA announced 7 major updates on the Safety and Technical Standards for Cosmetics (2015 version) with effect from May 1 onwards.

22 technical guidelines (draft) were issued in March 2021, and technical guidelines for products monitoring non-invasive blood / glucose will be drafted

The NHC announced the implementation of The Administrative Measures for the Clinical Use of Medical Devices coming into force from March 1, 2021 onwards.

The Guangdong MPA (Medical Products Administration) announced details about the pilot plan and the responsibilities of different departments involved.

The NMPA announced the implementation of a mNMPA Introduces the Medical Device Master Filing System covering both medical devices and IVDs.

First remote inspection successfully carried out in January 2021 for SELO China manufacturer license, and many more to come.

The NMPA announced a total of 28 updates on the classification catalogue for medical devices including 15 classification changes and 13 content updates.

AdvaMed advocates globally for the highest ethical standards and patient access to safe, effective and innovative medical technologies that improve lives.

On December 4, 2020, the CNCA announced the temporary guidelines for sampling testing on five groups of organic food products in China.

2 amendment drafts concerning the prohibited list of cosmetic ingredients & the IECIC (Inventory of Existing Cosmetic Ingredients in China) were released.