NMPA recognizes the urgent need for certain devices and IVDs. Those indicated for life-threatening illnesses can be granted Conditional Approval if the benefits of the product outweigh the risks. The manufacturer must also be committed to perform further clinical research.
NMPA’s Guideline on Conditional Approval for Medical Devices, released on December 20, 2019, includes the following:
- Premarketing clinical data must be able to show preliminary efficacy or to reasonably predict clinical value;
- Surrogate endpoints can be allowed;
- The expiration date on the approval certificate must be identical to the completion date of the post-market study;
- The risks must be shown on the label and IFU;
- The standards of safety and efficacy must be unchanged with regular market approval.
The Guideline also provides the contents of pre-clinical study and clinical study required before Conditional Approval and the acceptable forms of post-market after Conditional Approval.
One area where Conditional Approval can be applied is to 3D printed medical devices. The Customize-Designed Additive Manufactured (3D Printed) Medical Device Technical Review Draft Guideline issued on February 26, 2018, specifies that, when there is no predicate device to compare to (innovative products) with limited patient volume and no readily available referenced devices, NMPA is only asking for 10 to 20 pairs of an observatory study to be used in conjunction with historical data for general analysis. A three-month follow-up period is the minimum requirement to determine the observatory clinical benefits. With such a short endpoint and small sample size, NMPA is relying on post-market follow-up evidence for market approval.
Conditional Approval also applies for devices granted Innovation Status or Priority Review. Click HERE for the scenarios to apply and the approval status for Innovation Device and Priority Review in 2019.
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About ChinaMed Device, LLC
ChinaMed 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 (CFDA) 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 (CFDA) 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.