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Coronavirus product manual changes required for China

Coronavirus product manual changes are required by the NMPA in China. Notice No. 349 (2023) outlines important modifications for Coronavirus nucleic acids, antigens, and antibodies detection reagents.

March 13, 2026
Coronavirus product manual changes required for China
How to avoid animal testing in China for cosmetics | Cisema Webinar (Spanish)
How to avoid animal testing in China for cosmetics | Cisema Webinar (Spanish)

Avoid animal testing for general cosmetics and special cosmetics in China will be the main topic of this Spanish webinar

June 29, 2023
How to avoid animal testing in China for cosmetics | Cisema Webinar (Spanish)
China health food raw material update

China health food raw material update has been issued by the State Administration for Market Regulation, along with the NHC and the NATCM.

China health food raw material update
China prohibited cosmetic ingredient list update has been proposed

China prohibited cosmetic ingredient list update has been proposed by the National Institute for Food and Drug Control (NIFDC).

June 28, 2023
China prohibited cosmetic ingredient list update has been proposed
China medical device standards update plan 2023 is announced

China medical device standards update plan 2023 has been announced by the National Medical Products Administration (NMPA).

June 28, 2023
China medical device standards update plan 2023 is announced
IVD reagent registration change review draft guidelines

IVD Reagent Registration Change Review Draft Guidelines have been issued by CMDE in draft format for industry comment by June 30, 2023.

March 13, 2026
IVD reagent registration change review draft guidelines
China suspends bone graft material from HansBiomedCorp

China suspends bone graft material from HansBiomedCorp (South Korea) following a remote off-site inspection by the NMPA.

June 28, 2023
China suspends bone graft material from HansBiomedCorp
Physicochemical characterization of nanomaterials used in medical devices - New guidelines issued

Physicochemical characterization of nanomaterials used in medical devices encompasses the evaluation of various properties

June 1, 2023
Physicochemical characterization of nanomaterials used in medical devices - New guidelines issued
Registration of disposable light-proof infusion sets in China - Amended guidelines issued

Registration of disposable light-proof infusion sets in China shall refer to the technical review guidelines revised by the CMDE in April 2023

June 1, 2023
Registration of disposable light-proof infusion sets in China - Amended guidelines issued
Registration of disposable blood separation devices in China - Amended guidelines issued

Registration of disposable blood separation devices in China shall refer to the technical review guidelines revised by the CMDE in April 2023.

June 1, 2023
Registration of disposable blood separation devices in China - Amended guidelines issued
Registration of disposable infusion devices in China - Amended guidelines issued

Registration of disposable infusion devices in China shall refer to the technical review guidelines revised by the CMDE on April 28, 2023.

June 1, 2023
Registration of disposable infusion devices in China - Amended guidelines issued
Registration of blood dialyzers in China - Amended guidelines issued

Registration of blood dialyzers in China shall refer to the technical review guidelines revised by the CMDE on April 28, 2023.

June 1, 2023
Registration of blood dialyzers in China - Amended guidelines issued
Registration of blood dialysis concentrates in China - Amended guidelines issued

Registration of Blood Dialysis Concentrates in China shall refer to the technical review guidelines revised by the CMDE on April 28, 2023.

June 1, 2023
Registration of blood dialysis concentrates in China - Amended guidelines issued
Intense pulsed light therapy device registration in China - Guidelines amended

Intense pulsed light therapy device registration in China shall refer to the newly revised technical review guidelines issued in April 2023

June 1, 2023
Intense pulsed light therapy device registration in China - Guidelines amended
China motorcycle rearview mirror and helmet standard requirements implementation from July 2023 onwards

China motorcycle rearview mirror and helmet standard requirements - GB 15084-2022 and GB 811-2022 will come into effect on July 1, 2023.

March 11, 2026
China motorcycle rearview mirror and helmet standard requirements implementation from July 2023 onwards
Clinical trials of sodium hyaluronate complex solution - draft guidelines issued

Clinical trials of sodium hyaluronate complex solution have a set of draft guidelines issued by the China CMDE on May 17, 2023.

June 2, 2023
Clinical trials of sodium hyaluronate complex solution - draft guidelines issued
China registration of ophthalmic optical measurement devices - Technical review guidelines issued

China registration of ophthalmic optical measurement devices shall refer to the respective technical review guidelines issued by the CMDE

May 31, 2023
China registration of ophthalmic optical measurement devices - Technical review guidelines issued
Pre-communication for Hainan medical device clinical RWD application - Trial measures implemented

Pre-communication for Hainan medical device clinical RWD applications will be required to follow the CMDE trial measures.

May 31, 2023
Pre-communication for Hainan medical device clinical RWD application - Trial measures implemented
Registration platform for cosmetic raw materials safety information - Draft guidelines issued

The registration platform for cosmetic raw materials safety information in China helps ensure that businesses fulfill their responsibilit...

July 10, 2024
Registration platform for cosmetic raw materials safety information - Draft guidelines issued
Technical guidelines for reporting cosmetics formulas - draft issued

Technical guidelines for reporting cosmetics formulas were drafted by the National Institutes for Food and Drug Control.

June 1, 2023
Technical guidelines for reporting cosmetics formulas - draft issued

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