On September 6, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA (National Medical Products Administration) released a draft version of the technical review guideline on the quality homogeneity of metallic implants using additive manufacturing.
The product scope covers metal implants that can be customized to patients using powder bed fusion (PBF) in the manufacturing process. The guideline listed out basic requirements for research studies on performance:
1. The applicant shall evaluate or compare the consistency of the product in terms of chemical composition, geometric structure, microstructure and mechanical properties. Specifically, it includes chemical composition, size, porous structure, internal quality (defects, metal powder residues, etc.), microstructure, surface quality (surface defects, surface roughness), dynamic and static mechanical properties (shear properties, compression properties, tensile properties, bending properties, torsion properties), corrosion resistance, metal ion precipitation, etc.
2. The applicant shall describe the typical factors that may cause uneven quality in terms of software, equipment, powder raw materials, additive manufacturing process and post-treatment process, personnel, etc. used in additive manufacturing, and explain the influencing factors, possible risks, quality control indicators, etc.
On September 3, 2021, the NIFDC (National Institute for Food and Drug Control) released (No.14-2021) the draft version of the following YY standards:
- YY 0315-XXXX – Wrought titanium and titanium alloy dental implants
- YY 0272-XXXX – Dentistry-Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
- YY/T XXXX-XXX – Dentistry-Pre-capsulated dental amalgam
The YY standards were drafted by the Dental Instrument Inspection Center of the Peking University Hospital of Stomatology to replace the original YY 0315-2016 and YY 0272-2009. The draft documents provide definitions, performance requirements, corresponding test methods and specifications for the contents to be indicated on the packaging and marking.
Also, read our blog post about the 2021 draft amendment of the guiding principles for the shelf-life of passive implantable medical device for registration and filing released by the CMDE in June 2021.
Dental instruments and passive implants devices were both on the top five product groups of foreign origin to be registered in China in 2019 and 2020. We expect related new measures will be implemented as China continues to focus on strengthening the regulatory framework and market supervision of products belonging to these groups.
By Judith Sun, Colleen Xu, and Jacky Li. Contact Cisema if you would like to learn more.