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The NMPA issued the “Adjustment of Med Device Classifications Catalog (Draft)” on November 12, 2021, in a proposal to readjust classification, intended use and example names for 31 medical devices.
The NMPA published the “Registration Review Guideline for Domestic Class III and Imported Medical Devices”, specifying working processes and timelines of registration application, clinical application and change application. The document
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2021. These updates are presented by China Med Device, LLC, your partner in
The NMPA issued the “Notice regarding implementation of Medical Device Registration and Filing Management Measures and In Vitro Diagnostic Reagents Registration and Filing Management Measures” which have been effective since
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in September 2021. These updates are presented by China Med Device, LLC, your partner in
The last time the “Medical Device Registration Administrative Measures” were completely overhauled was in 2014. The newer regulations with significant changes have been introduced focusing on expediting innovation, complete product
NMPA issued the “Regulations on Self-test of Medical Device Registration (Draft)” on June 2, 2021, directing manufacturers on how to self-test and to submit the testing report. Decree 739 Regulation
NMPA issued the 2021 Medical Device Industry Standards Revisions Plan (draft) on May 26, in which 77 medical devices and IVDs are affected. The Standards Revisions are aimed to facilitate
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in May 2021. Policies Major Checkpoints for Adverse Event Monitoring
NMPA issued Notice regarding Medical Device Master Files Register on March 12, 2021. The draft was published in January 2019. Medical device master file in China is a technical document
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
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