Therapeutic Goods Administration (TGA) Australia has published a guidance document on the reclassification of medical devices in direct contact with the heart, central circulatory system (CCS) and central nervous system (CNS) in August 2021.
The guidance document aims to assist sponsors of medical devices intended to be used in direct contact with the heart, CCS, or the CNS with meeting their obligations and outlines transitional arrangements. These devices will be required to meet the regulatory requirements from the 25th of November 2021 and will need to demonstrate the safety and performance for Class III medical devices.
The requirements for reclassification include a more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device, conformity assessment documents demonstrating procedures appropriate for a Class III device, and mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.
Medical devices in direct contact with the heart, CCS or CNS will be reclassified to Class III, regardless of the duration of action of the device (transient, short-term, or long-term). Therefore, medical devices used in direct contact with the heart, CCS and CNS which are intended for transient or short-term use will be reclassified from Class IIa (low-medium risk) to Class III (high risk).
Necessary actions need to be taken to comply with the latest regulations and this will depend on the status of the product, such as medical devices included in the Australian Register of Therapeutic Goods (ARTG) prior to 25 November 2021, applications lodged before 25 November 2021, and applications submitted on or after 25 November 2021.
More details can be found in “Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems: Guidance on the transitional arrangements and obligations, Version 1.0, August 2021”: https://www.tga.gov.au/resource/reclassification-medical-devices-direct-contact-heart-central-circulatory-and-central-nervous-systems