Monday, 25, May, 2020 / Published in China, Medical Devices, News

Hainan Pilot Zone (Boao Lecheng)

Hainan is a large island off China’s south coast and the most southern province in China, known as China’s within-country…

Tuesday, 12, May, 2020 / Published in China, IVDs, Medical Devices, News

NMPA Solicits Public Opinions on the Reclassification of IVD Reagents

On 24.04.2020, the NMPA (National Medical Products Administration) announced a draft proposal to reclassify some of the IVD reagents in…

Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

NMPA UDI Database Officially Open to Public

On 10.12.2019, the NMPA (National Medical Products Administration) kicked off the pilot phase of the online UDID (unique device identification…

Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

Hainan MPA Accelerates Registration Approval for Overseas Medical Devices

On 31.03.2020, the Hainan MPA (Medical Products Administration) announced plans to boost the development of the medical and pharmaceutical industry…

Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

NMPA Temporary Rearrangements to Facilitate Registrations Affected by COVID-19

On 15.04.2020, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) announced (No.13-2020) temporary measures to…

Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

China Export Requirements for Coronavirus Protection Supplies

On 25.04.2020, the China’s Ministry of Commerce announced (No.12-2020) the requirements for exporting coronavirus detection reagents, medical masks, medical protective…

Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

NMPA Guidelines to Successfully Register Coronavirus Protection Supplies for Sale in China

On 30.03.2020, the NMPA (National Medical Products Administration) released an overview of the latest regulatory standards in response to the…

Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

Overseas Innovative Medical Device Approved by NMPA via Green Channel

On 23.04.2020, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) announced No.5-2020 the fast-track approval…

Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

NMPA releases its 2019 Annual Report for Medical Device Adverse Event Monitoring and Reporting

On 29.04.2020, the National Center for Adverse Drug Reaction (ADR) Monitoring of NMPA (National Medical Products Administration) released its 2019…

Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

NMPA Issues Revised Guidelines for Legal Agent Responsibilities for Adverse Events

On 10.04.2020, the NMPA (National Medical Products Administration) made the announcement No.25-2020 to provide guidance to NMPA Legal Agents on…