NMPA Regulations for AM Medical Devices
NMPA places high importance on the regulation of 3D-printed medical devices. Custom AM implants typically fall under Class III high-risk devices and are subject to strict registration reviews. To address the uniqueness of custom products, NMPA/CMDE has released a series of technical guidance documents.
As early as 2018, NMPA issued the Technical Review Guidance for Custom Additive Medical Devices, allowing pilot clinical evaluations with small observational samples (only 10–20 cases and 3 months follow-up) for innovative devices. Between August and October 2019, NMPA released five 3D printing device registration guidelines, covering implants for orthopedic, joint, spine, and maxillofacial use. These include review requirements for 3D-printed bone implants, acetabular cups, and vertebral bodies.
Recently, NMPA further refined the standards:
In 2022, it issued guidelines on Uniformity Study of Physicochemical Properties of Additive-Manufactured Metal Implants and Technical Requirements for Laser-Selective Melted Metal Materials for Oral Restoration.
Additional review points were provided for 3D-printed intervertebral fusion devices.
Overall, NMPA emphasizes quality control and performance consistency for 3D-printed orthopedic devices, requiring data on AM process validation, powder traceability, and residual powders after machining, along with compatibility testing by certified domestic labs.
To foster innovation, China has established a “Special Review Channel for Innovative Medical Devices,” offering priority approval and domestic substitution guidance for AM implants with significant clinical value. These policies and standards provide a clear regulatory path for registering and marketing orthopedic 3D-printed products in China.
Market Potential for 3D Printing in China’s Orthopedics
China’s orthopedic medical market is vast and rapidly expanding. The core driver is demographic:
By the end of 2020, China had 264 million people aged 60 and above (18.7% of the population), with 191 million aged 65+ (13.5%).
As the elderly population increases, issues like joint degeneration, osteoporosis, and fractures become more prevalent. Between 2010 and 2019, one tertiary hospital in China saw a fivefold increase in annual knee replacement surgeries, with 60–69-year-olds accounting for 36% of patients, indicating fast-growing demand for orthopedic surgery.
Market research estimates the Chinese orthopedic device market reached approximately $2.86 billion in 2023, with a projected compound annual growth rate (CAGR) of 6.9% from 2024 to 2030. Joint replacements and orthopedic implants accounted for 40.9% of the total market in 2023. Growth is driven by both a larger patient base and wider clinical adoption.
Policy support is also strong:
- The “Made in China 2025” initiative lists AM as a key development area.
- The revised Regulations on the Supervision and Administration of Medical Devices prioritize innovative device approval.
- The government promotes domestic alternatives to high-value imported consumables.
- Regions like Shenzhen and Shanghai have included domestically developed artificial joints in their medical reimbursement lists.
- These factors create multiple advantages for foreign 3D printing manufacturers entering the Chinese market:
- A large population offers a massive market for surgeries and rehabilitation devices.
- National policies encourage the introduction of advanced technologies and fast-track market entry through local pilot programs.
- Hundreds of hospitals have established 3D printing centers for preoperative planning and personalized treatment design.
- Many top-tier hospitals are performing complex spinal surgeries and bone defect reconstructions using 3D printing, with growing clinical expertise.
Overall, China ranks among the global leaders in orthopedic market size, growth rate, and unmet needs. With advanced technology and comprehensive solutions, international AM companies can find vast opportunities in this market.
Annex: Examples of Approved Orthopedic 3D Printing Devices by Foreign Manufacturers (per NMPA Database)
- Smith & Nephew: 3D Printed Redapt Modular Acetabular System
- Smith & Nephew: 3D Printed Total Knee System
- APEX Biomedical: Generic Additive-Manufactured Surgical Guide for Knee Replacement (non-sterile)
- Emerging Implant Technologies GmbH: Additive-Manufactured Porous Metal Intervertebral Fusion Device
