February 22, 2020
In this article we will provide a general introduction about Clinical Evaluation Report (CER) for medical devices registration and application in China. Current regulations in both China and EU require […]
February 21, 2020
Here’s the latest regulatory news for January 2020 affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague […]
February 19, 2020
While the Novel Coronavirus (COVID-19) has caused a tragic loss of life in China, the crisis demonstrates the flexibility of the country’s health agency. In just a couple of weeks, […]
February 14, 2020
NMPA CMDE (Center for Medical Device Evaluation) published Evaluation Reports for 23 innovative devices in 2019, aiding manufacturers on the vital points to obtain market approval, while committing itself for […]
February 12, 2020
NMPA published Registration Guideline on Novel Coronavirus Nucleic Acid Detection Reagent today (Jan 12), addressing the urgent needs of virus diagnostics. Accelerated Approval After issue of the Emergency Approval for […]
February 10, 2020
NMPA announced seven recalls in January 2020: Johnson & Johnson: Contact lens Philips Medical Systems: Medical angiography X-ray system Medtronic: Drug infusion system GE: Anesthesia system Biomet Orthopedics: Hip modular […]
February 7, 2020
China has accelerated the Emergency Approvals under the threat of Novel Coronavirus (“2019-nCoV”). National NMPA granted seven Emergency Approvals to Coronavirus Nucleic Acid Detection Reagent manufacturers in January, while provincial […]
February 6, 2020
NMPA published the Technical Guidelines on Medical Device Clinical Evaluation (draft) on January 2, 2020 for feedback. The draft Guidelines consist of three documents: Clinical Evidence – Key Definitions and […]
February 5, 2020
NMPA published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. Please see the summary below: Application […]
February 3, 2020
From regulatory submission to approval, it only took 2 days for a coronavirus nucleic acid detection kit to go to market. On January 28, Jiangsu provincial NMPA issued the Test […]
January 29, 2020
NMPA (CFDA) published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. The draft guideline was issued on […]
January 29, 2020
China national NMPA informed local NMPAs on Monday Jan 27 to allow import none -NMPA approval devices but have FDA approval, CE mark, or Japan approval, to help conquer 2019 […]