Here’s the latest NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2020. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Highest Law of Medical Device Industry Passed by State Council
The China State Council passed the “Amendment of Regulation on the Supervision and Administration of Medical Devices” on December 22, 2020. It is the finalization of the draft version issued on June 25, 2018.
Although the text of the Amendment has yet to be released, it is expected to exert significant influences on the industry, in respect to evaluation of safety and efficacy, procedures for registration, Unique Device Identification (UDI) implementation and penalties for illegal acts. On the other side, the regulations will also stimulate the innovation motivation of the industry. Click HERE for our analysis
NMPA Down-Classified Seven Class III Medical Devices
NMPA released the “Updated Medical Device Classification Catalogue” on December 31, 2020, in which fifteen categories of medical devices are down-classified, including seven class III and eight class II.
From December 31, 2020, NMPA will accept applications for registration and filing of medical devices based on the updated Classification Catalog. Click HERE for the full article
Fourteen Medical Devices Go into Hainan RWD Pathway
Fourteen medical devices and three drugs are piloting in the Real-World Data (RWD) Program in Hainan, according to RWD Initiation Meeting in Beijing on December 28, 2020. It is the second group of medical products trialed for RWD. The program, which has been piloted in Hainan since June 2019, was joined by eight overseas manufacturers. Among them, Allergan’s glaucoma treatment system was approved in March 2020. Click HERE for the full article
In Beijing, One Center Ethics Committee Review Sufficient for Multicenter Study
A “Beijing Medical Ethics Committee (EC) Review Mutual Recognition Alliance” was formed on December 1, 2020. The mutual recognition alliance currently consists of fifteen member institutes. The members of the Alliance will follow unified working rules and will recognize the ethical review based on the agreed review frequency and time. Click HERE for the full article
Feedbacks Needed for DR and Ultrasonic Diagnostic Software Guideline
NMPA announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI Software”. The notices, published on December 31, 2020, ask for public input which needs to be submitted by January 31, 2021. Click HERE for more information
NMPA Released Twelve Guidelines in One Day
NMPA released twelve guidelines on December 9, 2020, among them seven are for IVD products and five for nomenclature. Click HERE for the complete list
Another AI Software Approved by NMPA
NMPA granted Innovative Device Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise on December 1, 2020. This is the second AI innovative product approved by NMPA after the auxiliary triage software for coronary angiography image stenosis. Click HERE for full article
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.