NMPA published five guidelines for 3D printed devices from August to October 2019:
- Registration Guideline on 3D Printed Implantable Bone, Joint and Oral Hard Tissue
- Registration Guideline on 3D Printed Acetabular Cup (Draft)
- Registration Guideline on 3D Printed Vertebral Body (Draft)
- Registration Guideline on 3D Printed Patient Matching Mandibular Prosthesis (Draft)
- Technical Guideline on Mechanical Interaction Quality Control for Custom Bone Implants and Supporting Tools (Draft)
General Guidance: Observatory Study with Small Sample Size
NMPA has prepared regulatory establishments in the space since early 2018. 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 Real World Data Pilot Program in Hainan, please click HERE.)
The detailed outline translated by China Med Device (click HERE) can certainly help manufacturers in the space to generate the clinical data with different clinical indications much faster at much lower cost. With orthopedic and dental sectors growing at 20% or so annually, this guideline can certainly propel China to be the leader in 3D printed devices.
For a bilingual PPT on the background and principles of the 3D Printed Device Guideline authored by the NMPA committee member, please email info@ChinaMedDevice.com. China Med Device, LLC can help you understand 3D printed devices and get you ready for China market.
Following the general version of the 3D Printed Device Guideline, the 2019 Registration Guidelines Revision Plan issued on February 25 includes five 3D printed devices: 3D printed spine fusion cage, acetabular cup, spinal implants, bone implants and mandible. Make sure you are current with the guidelines when going through local type testing and registration for your 3D printed devices.
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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.