On June 1st, 2021, the newly revised Regulation on the Supervision and Administration of Medical Devices (Order 739 issued by the State Council) entered into force in China. Order 739 is the fundamental of all medical device/IVD regulations & guidelines in China. Manufacturers shall comply with Order 739 for all regulatory, clinical, manufacturing, and commercialization activities in China. more…
Following the implementation of Order 739 on June 1st, 2021, the China NMPA issued draft guidance on the Self-testing of Medical Devices for Registration. The draft is released to the public for opinions, with a deadline of June 20th, 2021.
How to expedite your registration？Is there any tips? Maybe the innovation path suits you!
The National Medical Products Administration (NMPA) thinks highly of the innovation of medical devices. Until now, a total of 109 innovative medical devices from 91 companies have been approved by NMPA, including four foreign ones. Please see the table below for the four enterprises.
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, Order 739. Four supporting regulations have been released today for public feedback with due date on April 25th, 2021. They have been working on these for a while already. You can send feedback online or email us. more…
An amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council on December 22, 2020. On March 16, 2021 the amendment was signed into law, Decree 739, with the effective date of June 1, 2021. more…
NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging System with Same Variety” on February 1, 2021. The 16-page document provides manufacturers detailed pathway for clinical evaluation, which is less time-consuming and more cost-effective than clinical trial. more…
NMPA issued the “2021 Medical Device Guidelines Revisions Plan” on February 9, 2021, in which 51 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type testing and make guidelines more consistent with the international counterparts. more…
The NMPA released the Annual Report for Medical Device Registration on February 5, 2021. In 2020, the NMPA accepted a total of 10,579 medical device initial registrations, registration renewals and registration changes, in which imported devices account for 61.1% of the total number. more…
NMPA published “Clinical Evaluation Guideline on Comparing the Medical Imaging Ultrasonic Diagnostic Equipment with the Same Variety” on January 19, 2021. The 27-page document provides manufacturers detailed pathway for clinical evaluation, which is less time-consuming and more cost-effective than clinical trial. more…
