Here’s the latest NMPA regulatory and clinical affairs news for medical device and IVDs pros for July 2020. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
More Class II & III Medical Devices and IVDs to be Exempted from Clinical Trial
CMDE published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 29, 2020 for feedback. The Catalog is to add exemptions for 53 medical devices (including 18 Class III devices) and amend product names and descriptions for 13 medical devices; It is to add exemptions for 15 IVDs (including 2 Class III IVDs).
If finalized, a total of 1,055 medical devices and 416 IVDs will be exempted from clinical trials in China since the first exemptions catalog issued in 2014. See full article HERE
Industry Standards to Facilitate UDI Adoption
NMPA “Rules for Unique Device Identification (UDI) System” mandates that the China UDI system for the first group of devices will take effect on October 1, 2020. By then those devices must be implemented with their UDI data into the China UDI data system with the qualified suppliers. NMPA formulized two standards on July 9, for database dataset and the filling of database respectively. See the UDI timeline, regulations and the list of the first group devices HERE
Allergan’s Dermal Filler Began RWD Pilot in China
The scale-up usage and clinical data collection plan for Juvéderm VOLUX, an Allegan manufactured injectable dermal filler, was launched in Hainan Boao Medical Pilot Zone on July 3, 2020.
The foreign-approved devices for urgent Chinese clinical needs, without predicates approved in China, can be imported to Hainan via the policy dated back to April 2018. And then Real-World Data (RWD) of the imported device can be collected to support the regulatory approval from national NMPA. The Volux filler has enrolled around 120 patients for the RWD pilot. See our comprehensive review HERE
| Unique Device Identification (UDI) effective date for 1st group devices | Oct 1, 2020 |
| Periodic Risk Evaluation Report (PRER) effective date | Sep 30, 2020 |
PRER Coming, Questions Addressed
A Periodic Risk Evaluation Report (PRER) is required to submit to NMPA, according to Decree No. 1 Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation. We publish the Q&A section to address the common issues arouse from manufacturers drafting PRER. Click link 1 and link 2.
Guidelines
NMPA published fourteen guidelines in July. The guidelines cover indications of ophthalmic, orthopedic, gastroenterology and urology, anesthesia, and immunology, etc. See the list of guidelines HERE
Standards
NMPA issued nine orthopedic standards on July 9, 2020, in which 3D printed devices, bone needle, allogeneic repair materials and others are affected. Also published are 31 standards, including seven for molecular diagnostics and seven for dental devices. See the list of standards HERE
Fast-Track Approval
Two Devices Obtain Fast-Track Status in July
NMPA granted Fast-Track Status to two medical device manufacturers in July, for the indications of Clinical Chemistry and Radiology, respectively. See the key takeaways for manufacturers 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. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.
