News

Improve the management of the electronic filing for drug registration applications, the NMPA developed and promoted the eCTD.

The NMPA has developed and built an API production and supply information collection module in the drug information collection platform.

The China GACC issued an explanatory document for China food importers to learn more about the expected requirements in January 2022.

N15 New Food Materials approved by the National Health Commission (NHC) on October 22, 2021. Read the original NHC announcement here...

NMPA Releases FAQ for Cosmetics Businesses in China in November 2021in related to the new CSAR framework for cosmetics

The NMPA published various technical guidelines covering specific topics on clinical trials, clinical evaluation, and animal testing.

Regulatory Measures for Self-testing finalized by National Medical Products Administration on October 22, 2022.

On October 29, 2021, the NMPA published the In Vitro Diagnostic Reagents Classification Rules for the first time as an individual document.

Since German Bundestag's SCDDA was passed, Cisema is recommended by IHK Pfalz to support German companies with supply chain audits in China.

The NMPA announced the regulations for the supervision and administration of children’s cosmetics. It will be implemented on January 1, 2022.

CMDE Drafted regulations for metallic implants using additive manufacturing and for dental implants and dentistry products

Technical review guideline for the clinical evaluation of Intravascular Catheters products in comparison with predicate devices was announced

On September 18, 2021, the China NMPA announced the implementation of a work plan to ensure product quality and safety for medical devices.

NMPA published a revised the clinical trial exemption list for medical devices and IVD reagents which became effective on October 1, 2021.

The CMDE released the draft of technical review guidelines for submission requirements of medical device clinical trial data.

Drug release studies may be required for combination products in China that intend to release drug components to certain parts of the body.

The NMPA announced the plan for the implementation of UDI for the remaining class III products which do not yet require UDI.

This is the first set of guidelines in China published specifically for nanomaterials used in medical devices in China.

The new medical device (Order 47) and the new IVD (Order 48) regulations will be effective from October 1, 2021 onwards.

NMPA published naming guidelines for Neurological and Cardiovascular Surgical Instruments & Medical Diagnostic and Monitoring Instruments