From 1st January 2021 after a pilot phase, the UDI requirements first becomes mandatory for the high-risk, i.e. Class III medical devices in China. The NMPA published a list which includes in total, 9 categories and 69 types of medical devices for initial UDI implementation. The devices which have already been placed on the Chinese markets and fall into these categories are exempted from the UDI requirements.
Category 1: Active surgical instrument
Cryosurgery equipment and accessories
Category 2: Non-active surgical instrument
Anastomosis (suture) instruments and materials
Category 3: Neurological and cardiovascular surgical instruments
Cardiovascular interventional devices
Category 4: Medical imaging devices
Capsule Endoscopy System
Category 5: Blood transfusion, dialysis and extracorporeal circulation devices
Hemodialysis and peritoneal dialysis apparatus;
Cardiopulmonary flow apparatus
Category 6: Active implantable devices
Cardiac rhythm management devices;
Neuromodulation devices;
Assistive bit hearing devices and
Implantable drug infusion devices
Category 7: Non-active implantable devices
Osseointegrated implants;
Spinal implants;
Joint replacement implants;
Neurological implants;
Cardiovascular implants;
Ear, nose and throat implants;
Plastic and general surgery implants
Category 8: Infusion, care and protection equipment
Implantable drug delivery devices;
Ureteral stent;
Absorbable surgical hemostatic material
Category 9: Ophthalmic devices
Artificial lens
Along with the full publication of the first group’s UDI device list, NMPA has also named three UDI issuing bodies, namely GS1 China, ZIIOT and AliHealth. Unlike the U.S. and EU, the UDI issuing bodies are accredited by the U.S. FDA and the European Commission. The Chinese NMPA has not publicly disclosed the accreditation process, but requires that the UDI issuing body must be a China-based legal entity with a sound management and operational system to ensure the uniqueness of the medical device unique identifier, created in accordance with its standards, and in compliance with China’s data security requirements. U.S. FDA and the European Commission have three common UDI issuing bodies, namely GS1, HIBCC and ICCBBA. Additionally, the European Commission also accredited IFA as an issuing body. However, GS1 is the only joint UDI issuing body in the U.S., EU and China. This may present challenges for global manufacturers in terms of supply management and regulatory document management. Therefore, it is essential to monitor global medical device regulatory development, especially UDI development at the international level, in order to plan ahead and avoid delays in product regulatory approval and launch.