Clinical Trial Guidelines Updated & Various Draft Product Guidelines Issued

On September 2, 2020, the Beijing MPA announced the clinical trial guidelines for medical devices in the Beijing municipalities. Required action items before, during, and after the clinical trial  were addressed.

Also, the CMDE (Center of Medical Device Evaluation, NMPA) announced the draft guidelines for the technical review of 3 test reagents and 1 medical device software, the clinicl trial of 1 test reagent, and the clinical evaluation for 2 medical devices.

Technical Review Guidelines (Draft)

• Test reagents for cryptococcus antigen
• Test reagents for rotavirus antigen
• Test reagents for mutation in deafness-associated genes
• Medical device software for cyber security
• Drug-device combined products (under development)

Clinical Trial Guidelines (Draft)

• Test reagents for anti-tumor medication already on the market

Clinical Evaluation Guidelines (Draft)

• Medical magnetic resonance imaging (MRI) system
• Ultrasonic cutting and hemostasis system for soft tissue

The CMDE began soliciting public comments once the draft guidelines were announced.

By Jacky Li. Contact Cisema if you would like to learn more.