Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros for January 2021. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
China’s UDI System for First Devices Group Effective January 1
Unique Device Identification (UDI) system took effect on January 1, 2021. For the devices listed in the “First Group of Unique Device Identification Devices” list, the applicant shall submit the unique identifier of unique device identification (UDI-DI) in the registration management system. For our comprehensive review please click HERE
16 Class III Devices Exempted from Clinical Trial
The NMPA released the “Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on January 19, 2021. 16 Class III devices and three Class III reagents are exempted from clinical trial.
A total of 1,090 medical devices and 423 IVDs has been exempted from clinical trials in China since the first exemptions catalog issued in 2014. For more information please click HERE
More Information Provided on the Pilot Trial in Greater Bay Area
The devices and drugs from Hong Kong and Macao public hospitals can be clinically used in Shenzhen Hospital of Hong Kong University, according to a joint announcement by Guangdong NMPA and seven provincial agencies. The deadline of the trial period is July 31, 2021.
With the current policy in the Greater Bay area, unapproved medical devices can be clinically used in the area, as long as they are used in Hong Kong and Macao’s public hospitals and are granted an import certificate by Guangdong’s provincial government. For more information please click HERE
Guidelines
Imaging Ultrasonic Diagnostic Equipment Clinical Evaluation Guideline Issued by NMPA
NMPA published Clinical Evaluation Guideline on Medical Imaging Ultrasonic Diagnostic Equipment with the Same Variety on January 19, 2021. The applicants shall conduct the clinical evaluation with the method of same variety comparison, based on the Guideline Basic Principles of Clinical Evaluation of Medical Devices. The differences to the predicate equipment shall be provided to demonstrate that the safety and effectiveness of the declared product are not impacted. For the two differences that NMPA takes as example, please click HERE
Three IVD Guidelines Released in One Day
NMPA published three IVD guidelines on January 19, 2021, covering genetics and microbiology. For the list please click HERE
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.
