May 5, 2020
On April 10, the NMPA issued the “Guideline for Medical Device Market Authorization Holders (MAHs) to Conduct Adverse Event Monitoring”. Based on Decree 1 Medical Device Adverse Event Reporting and […]
April 29, 2020
China mandated electrical medical device manufacturers to comply with its national mandatory standard GB 9706.1-2007, equivalent to IEC 60601-1 Edition 2, since 2008. Even though overseas manufacturers adopted IEC 60601-1 […]
April 27, 2020
China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (COVID-19) since late January. China Med Device, LLC, with its partner Musculoskeletal Clinical Regulatory Advisers (MCRA), […]
April 24, 2020
On April 23, 2020 NMPA CMDE (Center of Medical Device Evaluation) granted two innovative medical device status: Microtech Medical: Continuous Glucose Monitoring System Edwards Lifesciences: Transcatheter Valve Repair Clip NMPA […]
April 24, 2020
China National Medical Products Administration (NMPA) announced the suspension of importation, sales and use of Abraxane (nanoparticle albumin-bound paclitaxel) in China on March 25, 2020. Celgene, now a Bristol-Myers Squibb […]
April 20, 2020
NMPA published the notice Enhance Quality Inspection for Sterile and Implantable Medical Devices on April 14, 2020. Regulations to be Based upon Regulations for the Supervision and Management of Medical […]
April 16, 2020
Here’s the latest regulatory news affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague and opt-in here. […]
April 16, 2020
Under the COVID-19 crisis, China’s health regulators demonstrated unprecedented speed in providing approvals in mere weeks for needed medical devices, particularly for diagnostic test kits. Jiangsu provincial NMPA approved the […]
April 11, 2020
Despite the global outbreak of novel coronavirus (COVID-19), NMPA published 16 guidelines and 43 standards in March, guiding manufacturers with type testing and registration. For English version of any documents […]
April 9, 2020
NMPA issued the 2020 Medical Device Industry Standards Revisions Plan on March 20, in which 86 medical devices and IVDs are affected. The Standards Revisions are aimed to facilitate manufacturers […]
April 6, 2020
China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (Covid-19) since late January. Two regulatory authorities share the same progress: Emergency approval channels have been […]
April 2, 2020
The NMPA expert panel convening scientists, medical experts, government officials, manufacturer’s representatives and Clinical Research Organizations (CROs) from transcontinental locations is delivered online for the first time. The virtual conference […]