Since the coronavirus outbreak in China, 7 PCR assays and one software have been approved by the China National Medical Products Administration (NMPA) within one month. However, the PCR techniques are time-consuming and required for central lab processing. The China…
Author: jmedtec0
Approval of medical devices and IVDs within two weeks during the coronavirus emergency
Since the coronavirus outbreak in China, the China National Medical Product Administration (NMPA) and its provincial affiliates have initiated the emergency approval process for medical devices and IVDs in order to solve the shortage of medical supplies on the market.…
China allows overseas medical devices import without registration into the country due to the coronavirus emergency
Due to the coronavirus emergency, the China National Medical Product Administration has issued an opinion letter for openning the import of overseas medical devices which can be used during the coronavirus emergency. The medical devices do not need to be…
Some hospitals in the Greater Bay Area in China may exempt from the China NMPA registration for use the drug and medical devices registered in Hong Kong SAR
In the meeting that the Chief Executive of the Government Hong Kong Special Administrative region, Mrs Carrie Lam attended in Beijing on Nov 6th, 2019, 16 policy measures are introduced to offer further convenience to Hongkonger developing their careers, working…
Booming Healthcare Sector at the 2nd China International Import Expo (CIIE) held in Shanghai
The Second China International Import Expo (CIIE) was held in Shanghai from November 5 to 10, 2019.The rapid growth of medical devices and health market attracts enterprises from all countries to enter China’s big market. CIIE is quite a rare…
Must-read: NMPA Pre-submission consultation of Registration process for medical devices
The Chinese authority NMPA has made a carton illustration for a pre-submission consultation of registration process for medical devices.
NMPA officially joined the IMDRF National Competent Authorities Report information exchange mechanism
On September 19, at the 16th management committee meeting of IMDRF held in Yekaterinburg, Russia. The application to join National Competent Authorities Report information exchange mechanism of IMDRF submitted by the Chinese delegation was unanimously approved by the member states.…
China starts to implement UDI for certain Implantable Devices
On October 15th, 2019, Chinese National Medical Product Administration (NMPA) announced 64 types of medical devices required for the UDI implantation. All of them are classified as class III. Those devices listed shall be produced with UDI after October 1st,…
NMPA Overseas Audit at Medtronic, Inc. in the USA (2019/03/05)
License Holder: Medtronic, Inc. Address of License Holder: 710 Medtronic Parkway N.E. Minneapolis MN 55432 USA Manufacturing Site: 3800 Annapolis Lane Plymouth, MN 55447, USA. China Agent: Medtronic Shanghai Product: Artificial heart valve Type of Inspection: Regular Supervision Guidelines for…
China issues revised drug administration law on August 26th, 2019
On August 26th, 2019, China’s top legislature voted to adopt the revision to the drug administration law, which is an update from the version in the year of 2001. In the updated drug law, the concept of marketing authorization holder…