A list of recently published articles regarding medical device regulatory updates from the NMPA and other governing bodies in China.

China Issues Recommendation for Medical Device Clinical Data

For medical device registration in China, one of the most important documents to be provided is  clinical data. 

NMPA Issues New Guidance for Medical Device Software in China

In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.

Hong Kong’s MDD Formalizes Expedited Approval Scheme

Hong Kong’s Expedited Approval Scheme has been upgraded from a trial. Approvals from at least 2 GHTF countries plus China.

China’s Green Pathway Registration for Innovative Medical Devices

China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.

CHINA: REGULATORY AND COMMERCIAL UPDATES

The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China

CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.

China Regulatory and Commercial Updates

The NMPA has continued to stay busy this year, releasing numerous guidance documents and updates to their regulatory requirements. Here are some of the most important updates from the last few months.

Sales Target Spotlight: China’s Boao Hope City

The Chinese national government has established a special economic zone on Hainan Island with a focus on medical devices and wellness. Medical device manufacturers seeking sales growth in China should be aware of the Boao Hope City development particularly those with new and innovative devices.

NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China

Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.

Submission Changes in China: ToCs and the eRPS

Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.