NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification ”, due by May 3, 2021. AI technologies have the potential to transform health care by
The article below provides comprehensive technical review on AI-aided Software Guideline, released in June 2019. It was written by Elisa Mark and published on BioWorld, a Hong Kong-based biotech magazine,
The NMPA officially published the first guideline specifically for CDx reagents, the “Guideline for Technical Review and IFU Update for Oncology CDx Based on the Same Group of Therapeutic Drugs”
Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. Policies Highest Decree of Medical Devices Revealed New
The new “Regulation for Medical Device Administration and Supervision”, Order 739 LDT was released on Mar 18, 2021. The effective date is June 1, 2021. It will replace Order 680. Order
China NMPA moves fast to provide more details in support of the State Council “Regulation on the Supervision and Administration of Medical Devices”, to support Order 739. Four supporting regulations
The NMPA published “Guidelines Revisions for 22 Class II Medical Devices” on March 17, 2021. Feedback needs to be submitted by April 17, 2021. It is responding to the “2021
NMPA issued 2020 Adverse Events Report on March 22, 2021, summarizing over 530,000 reports, 35.25% rise from the year before. “Medical device manufacturers should take the initiative to collect all
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
New China NMPA Reform titled “Regulation on the Supervision and Administration of Medical Devices”, or Order 739, long-awaited overarching policy, is finally released. It was adopted by the China State
Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros in February 2021. These updates are presented by China Med Device, LLC, your partner in
Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros for January 2021. These updates are presented by China Med Device, LLC, your partner in
Email: info@chinameddevice.com
Phone: 978-390-4453
Office:
800 Turnpike St. Ste 300
North Andover, MA, 01845
