May 5, 2020

NMPA Guideline for MAH: Eight Major Requirements on Adverse Event Monitoring

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

Reduced Time and Cost: China Plans to Adopt Latest Edition of IEC 60601-1

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 Med Device to Hold RAPS Webinar on China & U.S Regulatory Response to COVID-19

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

NMPA: Two Devices Granted Innovation Status

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 NMPA Overseas Inspection Results in Suspension of Importation

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

Updated NMPA Quality Inspection: Sterile and Implantable Devices

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

NMPA News Roundup 202003

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

Regulatory Guidance on COVID-19 Give IVD Manufacturers Lessons on Seeking China Approval

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

NMPA under Pandemic: Record Number of Guidelines and Standards Issued in March

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 Standards Revisions Plan: Nine Mandatory Standards to be Issued in 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

NMPA V.S FDA — Regulatory Response to the Coronavirus (COVID-19) Pandemic

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

NMPA’s Multinational Expert Panel Meeting Going Virtual

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 […]