On August 26, 2021, the NMPA (National Medical Products Administration) published (No.65-2021) Part I of the Technical Guidelines for the Evaluation of Safety and Effectiveness of Nanomaterials in Medical Devices: System Framework.
Definition of Nanomaterials
According to the national standard GB/T30544.1, nanomaterials are materials with any external dimension, internal or surface structure at the nanoscale with the size range between 1 nm and 100 nm. The properties of the nanomaterials should be unique and not be found in larger sized particles at the macroscopic scale or out of the nanoscale range.
|The guidelines are applicable to:|
| – The evaluation of the safety and efficacy of medical devices that come into direct or indirect contact with the human body and that consist of or contain nanomaterials.|
|The guidelines are not applicable to:|
| – In Vitro Diagnosis (IVD) products that apply nanomaterials, but may be relevant when considering the effectiveness of IVD products. |
– Enabling technologies for the application of nanomaterials.
– Pharmaceutical products with applications of nanomaterials.
– Occupational and environmental risks posed by medical devices applying nanomaterials during manufacture and disposal.
Applicants should confirm the suitability of the test system by designing a series of tests to establish a biological evaluation test protocol that is suitable for the characteristics of the declared product.
The following potential risks should be taken into account:
- The possibility of free nanoparticles released from the device
- The dosage number of free nanoparticles released
- The duration of the release of free nanoparticles
- The route of contact with the body and which part of the body the free nanoparticles were exposed to.
- Even if the medical device does not contain nanomaterials, the wear and tear itself can create nanoscale particles.
The guidelines may also be applicable to medical devices that contain particles with the size bigger than 100 nm that may possess different properties and safety risks.
There are four major steps during the risk evaluation process:
- Evaluate the possibility of nanoparticles released directly or due to wear and tear of the device
- Particle distribution and persistence
- Hazard assessment (Biological/toxicological evaluations)
- Risk assessment
According to the guidelines, the applicants may also consider to collect post-market real-world data that will help reflect the benefits and risks of the devices, and develop risk control measures.
This is the first set of guidelines in China published specifically for nanomaterials used in medical devices in China, and we expect more developments on the respective regulatory framework announced in the near future.
By Dora Yang and Jacky Li. Contact Cisema if you would like to learn more.