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The Guangdong government released the “Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial)” to encourage medical device and IVD manufacturers to transfer the certificates
The NMPA issued four draft guidelines today on September 28, 2022, soliciting public opinions. Your NMPA guidelines feedback needs to be submitted by November 14, 2022. NMPA Guidelines Feedback Requested
The NMPA published 67 review reports from January to September 2022. Three categories are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including Boston Scientific, Edwards Lifesciences
The NMPA published the 27 registration review guidelines on September 15, 2022, which involve a wide range of indications, from chemistry, hematology to dental and urology, etc. It is to
The NMPA released eleven filing review guidelines on September 1, 2022. Equivalent to FDA’s Acceptance and Filing Reviews, it is intended to be used by NMPA reviewers and the device
The NMPA issued the “Announcement on the transformation of 92 mandatory industry standards and research projects for medical devices into recommended industry standards and research projects” on September 9, 2022.
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in August 2022. These updates are presented by China Med Device, LLC, your partner
The NMPA released the draft version of “Registration Guideline for Radio Frequency Aesthetic Devices” on August 26. 2022 for feedback. Opinions need to be submitted by September 18, 2022. The
The NMPA granted Innovation Approvals to two overseas manufacturers in August 2022: Ethicon: Oxidized Regenerated Cellulose (ORC) powder BioFire Diagnostics: Meningitis/Encephalitis (ME) detection panel What are the Devices The NMPA
The NMPA published eighteen industry standards on August 22, 2022, to guide manufacturers for local type testing and regulatory approval: YY/T 0325-2022 Disposable sterile urinary catheter YY/T 0334-2022 General requirements
The NMPA issued Q&A for 34 common issues aroused in medical device type testing and registration. Full List of NMPA common issues If you have similar questions for your device
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen,
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