Regulatory News from Across Asia-Pacific

6 technical guidelines & 4 GB / YY draft standards were announced; 2 products registered & 7 applications accepted by the fast-track approval pathway.

On February 5, the NMPA issued a report covering a breakdown of the total existing and new standards for medical devices in 2020.

On January 19, the NMPA announced the new clinical trial exemption list for medical devices and in-vitro diagnostics reagents.

A total number of 10579 applications and 9849 approvals for medical device registrations in China were reported in 2020 along with a detailed breakdown.

The SAMR addressed the basic requirements for registration and filing management of cosmetics and new cosmetic ingredients in China to begin on May 1, 2021.

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The National Health Commission announced new food ingredients and additives are permitted to be used in food-contact articles.

On November 26, 2020, the SAMR announced the temporary measures for on-site inspection on special food products in China.

Five health food ingredients to be filed according to the directory and technical requirements for raw materials from March 1, 2021 onwards.

The NMPA announced various updates regarding soap, toothpaste, hair removal, hair growth, breast beauty, body slimming and deodorizing products.

The NIFDC released 7 technical draft proposals for detecting chemical agents and the evaluation of efficacy claims in cosmetic products in China.

Ultrasonic coupling agents are reminded to comply with mandatory standards and any necessary filing changes must be completed by the end of February 2021.

The new draft clarifies the registration requirements and categorization method of different drug-device combination products in China.

3 GB standards announced; 14 technical guidelines and 2 draft guidelines were issued; 6 medical devices pending for fast-track approval

Due to the 2020 performance of the fast-track approval process for medical device registration in China, the CDME plans to implement a smart review process.

The China SAMR published the new ordinance TSG 23 covering previous regulations such as TSG R1003-2006, TSG R4001-2006, TSG R7002-2009, and TSG R7003-2011.

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The SAMR issued the 2020 directory of health food raw materials and nutrient supplements, expanding the number of approved health claims.

The NMPA issued guidelines to address the standard procedure of submitting risk evaluation reports after the occurrence of adverse events.

The CMDE shared a timeline of events for establishing regulatory control on AI medical devices and shared the latest status of their upcoming plans.