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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]