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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 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
Here are the latest China NMPA Regulatory and Clinical Affairs news for medical device and IVDs pros for July 2022. These updates are presented by China Med Device, LLC, your
The NMPA released the “Guideline for Fundamental Principles Compliance of Medical Device Safety and Performance”, elaborating the risk-based approach for medical device registration review. Article 13 of “Administrative Measures for
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in June 2022. These updates are presented by China Med Device, LLC, your partner
The NMPA granted Innovation Approvals to three gastroenterology and urology devices in June 2022: Ultrasound diagnostic equipment for gastrointestinal endoscopy Disposable cryoablation balloon catheter Laparoscopic surgery system China NMPA Innovation
The NMPA released 55 revised or newly established medical device standards on May 18, 2022, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The Standards
Hainan Boao special zone allows overseas unapproved medical devices, IVDs, drugs in China to be used. In addition to the overseas medical products being sold and commercialized faster through this
Unique Device Identification (UDI) will be implemented with all Class III devices and IVDs, effective from June 1, 2022. It was announced by NMPA at the “Notice on Applying Unique
Here are the latest China regulatory and clinical affairs news pieces for medical devices and IVDs in February 2022. These updates are presented by China Med Device, LLC, your partner
The NMPA issued the “Guideline on Artificial Intelligence Medical Devices (Draft)” on June 4 for feedback. The document is to direct manufacturers on how define, design, and register the AI
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