NMPA issued four orthopedic guidelines on June 9, 2020 to guide manufacturers for local type testing and regulatory approval.
China has surpassed Japan as the second largest market for orthopedic medical devices in the world. With an aging population and improvement in health insurance policies, the demand for orthopedic surgeries in China, such as total knee replacement, ankle fracture and spinal fusion, have been increasing rapidly.
For market overview on orthopedics, please click HERE.
In terms of 3D printing for orthopedic applications, the “Customize-Designed Additive Manufactured (3D Printed) Medical Device Technical Review Draft Guideline” was issued on February 26, 2018. It 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. It can be used in conjunction with historical data to do the general analysis. A 3-month follow up period is the minimum requirement to determine the observatory clinical benefits. It is relying on post market follow up evidence with such a short endpoint and small sample size.
Other guidelines published in June include:
NMPA also consolidate information from manufacturers for incoming molecular diagnostics and immunology guidelines. If you make the following IVDs, please email us and we will send you the NMPA template and provide the translation service for you.
For information collection on companion diagnostics, please see our comprehensive review HERE.