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 […]
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 […]
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), […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]