Regulatory News from Across Asia-Pacific

New Medical Device Classification Catalogue was announced in draft on November 9, 2021, by the China NIFDC

Annual QMS self-inspection reports have new filing instructions and new report submission requirements currently in draft.

OEM quality agreement for medical devices helps to set out the the rights, obligations and responsibilities of registrants, filers and OEM...

Medical device clinical trial data submissions in China should now refer to the the NMPA technical review guidelines issued on Nov 25, 2021.

22 high-risk medical implants have been added in the draft catalogue of medical device products to be prohibited from China OEM production.

The NMPA issued a list of common violations committed by medical beauty service providers in China throughout 2020 and 2021.

Cisema presented on the topic of registration and approval of medical devices in China to 94 participants, and held a Q&A session after.

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.