Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros from May 2020. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
Annual Risk Assessment Report: PMS Requirements Further Specified
A Periodic Risk Assessment Report is required to submit to NMPA, according to Decree No. 1 Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation. However, some aspects remained unclear such as when to submit the report after COVID outbreak. NMPA published “Issues on Implementation of Periodic Risk Assessment Report for Medical Device Adverse Events” on May 6, clarifying the submission date, submission cycle, combined report for devices with multiple registration numbers, etc. For full article please click HERE
Guideline on Raw Material Changes for Non-active Devices: Eleven Examples
NMPA implemented the “Guideline on Raw Material Change Evaluation of Non-active Device” on May 19, 2020. The 22-page guideline describes four types of raw material changes that trigger the potential re-registration or re-evaluation. It also lists eleven devices as example.
To see the four material changes and other highlights from the guideline, please click HERE
NMPA Approves the First Medical Device Through Real-World Data Program
Allergan’s Glaucoma treatment system became the first medical device obtained NMPA Approval through Real-World Data (RWD) program. The RWD program, which has been piloted in Hainan since June 2019, was joined by eight overseas manufacturers.
In December 2019, NMPA issued the “Guideline on Real-World Data Used in Medical Device Clinical Evaluation (Draft).” The guideline specifies six sources of RWD and eleven situations where RWD can be utilized in China. For detailed information on the approval notice and RWD guideline, please click HERE
Guidelines
NMPA published nine guidelines in May, guiding manufacturers with type testing and registration:
- Technical guideline on medical device human-factor
- Registration guideline on vertebroplasty balloon dilatation catheter
- Registration guideline on acrylic resin bone cement for artificial joint replacement
- Registration guideline on metal intramedullary nail system
- Registration guideline on vaseline gauze
- Registration guideline on hydrocolloid dressing
- Registration guideline on follicle aspiration needle for assisted reproduction
- Registration guideline on spinal implant clinical evaluation quality control
- Registration guideline on dengue virus nucleic acid detection reagents
For English version of any guideline above, please email info@ChinaMedDevice.com.
Innovative Approval
Record Number of Devices Obtain Innovation Status in May
NMPA granted unprecedented number of innovative status to medical device manufacturers in May, including three foreign manufacturers and six domestic ones. For the full list of devices and the qualifications for innovation approval, 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 and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.