As the advancement of the technology of medical devices is progressing, more medical devices have been incorporated with nanomaterials served as part of their features. The authority emphasises mitigating the risk of nanomaterials in consideration of the safety and effectiveness, including chemical, physical and biocompatibility.
Recently, this amendment has been made by the Therapeutic Goods Administration (TGA) on the existing Essential Principle 7 to include the additional obligations to nanomaterials in use:
7.7 Minimization of risks associated with nanomaterials
- 1. A medical device must be designed and produced in a way that ensures that any risks associated with the size and the properties of particles which are, or can be, released into a patient’s or user’s body are minimized.
- 2. In minimizing risks, particular attention must be paid to the use of nanomaterials.
- 3. Subclause(1) does not apply to particles that come into contact with intact skin only.
The definition of “nanomaterial” in the Therapeutic Goods (Medical Devices) Regulations 2002 is stated as: Nanomaterial has the meaning given by Article 2(18) of Regulation 2017/745 (as in force from time to time) of the European Parliament and the Council of the European Union.
The amended Essential Principles Checklist can be viewed and downloaded from TGA’s website.
- I. Changes to medical device essential principles for nanomaterials
- II. Essential principles checklist (medical devices)
- III. Therapeutic Goods (Medical Devices) Regulations 2002