June

June 30, 2020
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CMD New Webinar! Learn China Mandatory Period Risk Evaluation Report (PRER) and the latest PMS Requirements in China NMPA and US FDA

Thursday, July 9, 2020 | 12:00 pm – 1:10 pm ET Register Now! China has been increasing its surveillance on post market monitoring with more regulations and random inspections both […]
June 22, 2020

NMPA Updates: Four Orthopedic Guidelines Published in One Day

NMPA issued four orthopedic guidelines on June 9, 2020 to guide manufacturers for local type testing and regulatory approval. Registration Guideline on 3D printed acetabular cup products Registration Guideline on […]
June 22, 2020

China Real World Data Adoption: Faster Introduction for Urgently Needed Devices

 “Regulations on the Management of Imported Medical Devices Urgently Needed in the Hainan Pioneer Zone” was published by Hainan government on June 2, 2020. This important document mandates the qualification […]
June 18, 2020

86 NMPA Standards to be Issued in 2020: Cosmetic Surgery, Cardiovascular and More

NMPA issued the finalized version of 2020 Medical Device Industry Standards Revision Plan on May 19, in which 86 medical devices and IVDs are affected. The Standards Revisions are aimed […]
June 12, 2020

NMPA News Roundup May 2020

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros from May 2020. These updates are presented by China Med Device, LLC, your partner […]