Blogs

February 19, 2020

Coronavirus Spurs Emergency Device Approvals in China; Reveals Lessons for Manufactures to Speed Market Entry (I)

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

23 NMPA Device Evaluation Reports in 2019: Guide Manufacturers for Market Entry

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 Guideline on Coronavirus Nucleic Acid Detection Reagent Published Today

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: Seven Recalls Announced in January 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

Emergency Approvals Surged under Coronavirus Outbreak

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 […]