Regulatory Updates for Medical Devices with Medicinal, Microbial, Recombinant, or Animal Origin Substances

New regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances have been introduced to align with EU standards and reduce regulatory burdens. These changes impact classification, conformity assessments, and information requirements.

Key Regulatory Changes

• Classification Rule 5.5 Amendment
• Devices containing microbial or recombinant origin substances are no longer automatically classified as Class III and may be reclassified to lower classes.
• Animal Tissue or Cell Products
• Devices containing non-viable animal tissues or cells must now provide specific information in their instructions for use.
• Removal of Special Conformity Assessment Requirements

The previous requirements for “”specified medical devices”” have been repealed, allowing recognition of a broader range of overseas regulatory approvals by the Therapeutic Goods (Medical Devices) Authority (TGA).

Transition Timeline & Compliance Requirements

Sponsors must transition their medical devices to the new classification by July 1, 2026, or cease supply.

Reclassification applications

Require a fee but are not subject to mandatory audits unless concerns arise.

These updates aim to streamline regulatory processes while ensuring the safety and effectiveness of medical devices in the market.

Source: https://www.tga.gov.au/resources/guidance/understanding-requirements-medical-devices-containing-medicinal-microbial-recombinant-or-animal-origin-substances

Region: South East Asia