Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines

Yesterday (21-August-2023) Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of Medical Devices" which assist sponsors comply with new regulations.

The multiple guidances are

1. Reclassification of Active Medical Devices for Therapy with a Diagnostic Function

Active medical device for therapy means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to support, modify, replace or restore biological functions or structures for the purpose of treating or alleviating an illness, injury or handicap.

The purpose of this guidance is to assist sponsors of active medical devices with a diagnostic function in complying with new regulations and outlines transitional arrangements.

2. Reclassification of Medical Devices in Direct Contact with the Heart, Central Circulatory, and Central Nervous Systems

Using this guideline, sponsors of devices that are intended for direct contact with the heart, central circulatory system (CCS), or central nervous system (CNS) will be able to meet their obligations. Transitional arrangements are also provided to help comply with new regulations.

3. Reclassification of Medical Devices that Administer Medicines or Biologicals by Inhalation

The purpose of this guidance is to assist sponsors of medical devices that administer medicines or biologicals by inhalation in meeting their obligations. It also outlines transitional arrangements to assist sponsors in meeting new regulations.

4. Reclassification of Medical Devices that are Substances to be introduced into the Body or applied to and Absorbed by the Skin

This guidance is specific to medical devices that are composed of substances or combinations of substances intended to be introduced into the body via an orifice or applied to the skin and absorbed by the skin. The guidance provides transitional arrangements to help sponsors meet the new regulations, it will assist sponsors of medical devices that are substances for introduction into the body in meeting their obligations.

5. Reclassification of Spinal Implantable Medical Devices

This guidance is intended to assist sponsors and manufacturers of spinal implantable medical devices in understanding and complying with new regulatory requirements. To meet regulatory requirements, the classification of a spinal implantable medical device determines the safety and performance requirements to be demonstrated.

Variations to Prescription Medicines - Excluding Variations requiring Evaluation of Clinical or Bioequivalence data, Appendix 2: Variation types - Biological Medicines

The TGA registration process for prescription medicine applications needs to be supported by nonclinical, clinical, and/or bioequivalence data (category 1 and category 2). This guidance outlines the types of variations and changes that can be made to biological medicines currently on the Australian Register of Therapeutic Goods (ARTG).