On 29 March, Australia’s regulatory agency, Therapeutic and Good Administration (TGA), updated its Medical Devices Essential Principles checklist by adding requirements for nanomaterials to adapt to a changing landscape and thus ensure an innovative and competitive market.

The Medical Devices Essential Principles checklist is the document listing all the essential requirements necessary to demonstrate the safety and efficacy of the Medical Device intended to be marketed in the territory.

The general requirements are divided into two main sections: general requirements and design and construction requirements. The general requirements are dedicated to the safety and efficacy of the Medical Device while the design and construction requirements describe the design and component aspects, including those related to manufacturing and composition.

The change reported on 29 March concerns General Requirement 7, where it is expressly required to find adequate information and evidence on the chemical and physical properties and biocompatibility of nanomaterials. This requirement was already present in the previous checklist, but details have been inserted to further clarify it without introducing additional obligations.

Specifically, as expressed in point 7.7:

  1. a Medical Device must be designed and manufactured to ensure the minimisation of risks associated with the size and properties of particles that are or may be released into the body of the patient or user;
  2. care must be taken in the use of nanomaterials to minimise risk;
  3. point 1 does not apply to particles that only come into contact with healthy skin.

As mentioned above, this change was made in order to adapt to a changing market and to ensure that patients and users have access to the latest medical technology at all times.

Do you want to know all the requirements for the marketing of Medical Devices and IVDs in the Australian market?

Contact us for information.