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February 22, 2020
medical device CER

Clinical Evaluation Report (CER) for Medical Devices/IVD in China

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

NMPA News Roundup January 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

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 […]
February 6, 2020

NMPA New Clinical Guidelines to be More Harmonized with International Standards

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

Summary of NMPA Tumor Mutation Reagents Guideline

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

Two-Day to Get Emergency Approval: Combat China Novel Coronavirus

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 Finalizes Tumor Mutation Reagents Guideline for CDx

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

Urgent Needs of Medical Products to Combat 2019 Novel Coronavirus

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 […]