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.
A list of recently published articles regarding medical device regulatory updates from the NMPA and other governing bodies in China.
For medical device registration in China, one of the most important documents to be provided is clinical data.
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 Expedited Approval Scheme has been upgraded from a trial. Approvals from at least 2 GHTF countries plus China.
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.
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
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.
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.
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.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
Chinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.
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