NMPA issued four orthopedic guidelines on June 9, 2020 to guide manufacturers for local type testing and regulatory approval.
- Registration Guideline on 3D printed acetabular cup products
- Registration Guideline on 3D printed artificial vertebral body
- Registration Guideline on Total knee prosthesis system products
- Registration Guideline on Heat and moisture exchanger
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.
For an English copy of 3D Printed Medical Device Draft Guideline, please email info@ChinaMedDevice.com. For outline of the guideline, please click HERE.
Guidelines in June
Other guidelines published in June include:
Software
- Medical Device GMP-Guideline on Standalone Software On-site Inspection
- Technical Guideline on Medical Device Software
Cardiovascular
- Registration Guideline on Lung ventilation test products
Plastic Surgery
- Registration Guideline on Facial implant prosthesis
Anesthesiology
- Registration Guideline on Heat and moisture exchanger
Physical Medicine
- Registration Guideline on Low frequency electrotherapy
General Hospital
- Registration Guideline on Electric air pressure hemostat
- Registration Guideline on Audiometer
- Registration Guideline on Hot compress (bag) products
- Registration Guideline on Medical carbon dioxide incubator
Gastroenterology/Urology
- Registration Guideline on Shockwave Therapeutic Apparatus
Opinion Wanted
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.
- Companion diagnostics
- Mycoplasma pneumoniae IgM/IgG antibody detection reagent
- Rotavirus antigen detection reagent
- Fluorescence quantitative PCR analyzer
- Group B Streptococcus nucleic acid detection reagent
- Human parvovirus B19 IgM/IgG antibody detection reagent
For information collection on companion diagnostics, please see our comprehensive review HERE.