NMPA issued nine orthopedic standards on July 9, 2020 to guide manufacturers for local type testing and regulatory approval. Their implementation date is June 1, 2021.
- YY/T 1701-2020 Medical Ti-6Al-4V/Ti-6Al-4V ELI powder for additive manufacturing
- YY/T 0345.1-2020 Surgical implants Metal bone needles Part 1: General requirements
- YY/T 0513.2-2020 Allogeneic repair materials Part 2: Deep low temperature frozen bone and frozen dry bone
- YY/T 0651.3-2020 Surgical implants Wear of total hip joint prosthesis Part 3: Load and displacement parameters of rail bearing type wear testing machine and related test environmental conditions
- YY/T 0726-2020 Passive Surgical Implant Devices General Requirements
- YY/T 0809.12-2020 Surgical implants Part and total hip prosthesis Part 12: Test method for acetabular cup deformation
- YY/T 1133-2020 Passive surgical implant combined instrument metal bone drill
- YY/T 1714-2020 Standard method for finite element analysis of non-assembled metal hip joint femoral stem
- YY/T 1736-2020 Test method for evaluating the durability and deformation of knee joint tibial pads under high flexion conditions
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.
Among the nine standards is one for additive manufacturing. 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.
Other Standards Issued on July 9
Also issued are 31 standards, including seven for molecular diagnostics and seven for dental devices.
- YY/T 1216-2020 Alpha-fetoprotein determination kit
- YY/T 1721-2020 free thyroxine determination kit
- YY/T 1722-2020 Prealbumin determination kit (immunoturbidimetry)
- YY/T 1724-2020 kit for determination of free triiodothyronine
- YY/T 1725-2020 Multiple nucleic acid detection kit for bacterial and fungal infections
- YY/T 1729-2020 Fungal (1-3)-β-D Glucan Assay Kit
- YY/T 1731-2020 Human Gene Single Nucleotide Polymorphism (SNP) Detection Kit
- YY/T 1723-2020 high-throughput gene sequencer
- YY 1727-2020 Human immunodeficiency virus antibody detection kit for oral mucosal exudate (colloidal gold immunochromatography)
- YY/T 0010-2020 Special technical conditions for intraoral imaging dental X-ray machine
- YY/T 0628-2020 Dental science Graphic symbols for dental equipment
- YY/T 0803.2-2020 dentistry root canal instruments part 2: enlarged drill
- YY/T 1696-2020 Dentistry Intraoral shaping knife
- YY/T 1732-2020 Special technical conditions for oral curved tomography X-ray machine
- YY/T 1715-2020 Surgical implants Yttrium oxide stabilized tetragonal zirconia (Y-TZP) ceramic material
- YY 0485-2020 disposable cardioplegia perfusion device
- YY/T 0694-2020 Standard Test Method for Elastic Retraction of Balloon Expansion Stent
- YY/T 1739-2020 Cardiopulmonary bypass system centrifugal pump head
- YY 0899-2020 General requirements for accessories of medical microwave equipment
- YY/T 0286.4-2020 Special infusion set Part 4: Infusion set for disposable pressure infusion equipment
- YY/T 1711-2020 Gating interface for radiotherapy
- YY/T 1730-2020 disposable hemodialysis catheter
- YY/T 1734-2020 iodine protective cap for peritoneal dialysis
Obstetrical and Gynecological
- YY/T 1698-2020 Medical devices for human extracorporeal assisted reproduction technology
- YY/T 1708.1-2020 Basic requirements for connectivity of medical diagnostic X-ray imaging equipment Part 1: General requirements
- YY/T 1726-2020 concentration gradient agar diffusion drug sensitive strip
- YY/T 0802-2020 Disposal of medical devices Information provided by medical device manufacturers
- YY/T 1709-2020 Uncertainty evaluation of calibrators for in vitro diagnostic reagents
- YY/T 1716-2020 Tissue engineering medical device products characterization of ceramic and mineral scaffolds
- YY/T 1752-2020 Basic data set of medical device unique identification database
- YY/T 1753-2020 Filling in the unique identification database of medical devices