Here’s the latest China regulatory and clinical affairs newsletter for medical device and IVDs pros in February 2021. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
2021 Guidelines Revisions Plan Issued by the NMPA
The NMPA published the “2021 Medical Device Guidelines Revisions Plan” on February 9, 2021, in which 51 guidelines are affected.
The plan involves the guidelines for technical review for type testing, clinical trial and registration, and Indication for Use (IFU) writing. For the importance of the plan and the list of guidelines please click HERE
Dental and Imaging Equipment Imported Most in 2021
The NMPA released the “Annual Report for Medical Device Registration” on February 5, 2021. In 2020, NMPA accepted a total of 10,579 medical device initial registrations, registration renewals and registration changes, in which imported devices account for 61.1% of the total number. Despite the impact of the pandemic, the total number of acceptance increased by 15.6% compared with 2019.
The top five categories of imported Class III medical devices are: dental equipment, medical imaging equipment, passive implantation equipment, neurological and cardiovascular surgery equipment, and ophthalmic equipment. Among them, dental equipment increased from 57 in 2019 to 66 in 2020, a jump of about 15.8%.
In 2020, the United States, Germany, Japan, South Korea, and Switzerland ranked the top five as the home countries for the initial registrations. For more information click HERE
Magnetic Resonance Imaging System Clinical Guideline Issued
NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging System with Same Variety” on February 1, 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
Four Imported Devices Go into Fast-Track Channel
NMPA granted nine manufacturers innovation approval and priority review status in February, including four overseas ones: Mevion Medical Systems, Biosense Webster (Israel), EyeYon Medical Ltd, XVIVO Perfusion AB. For the complete lists with the qualification of the two fast-track channels 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.