xi) Implantable medical devices and surgically invasive medical devices for long term use (a) Subject to clauses (b), (c) and (d), an implantable medical device or a surgically invasive medical device intended for long term use shall be assigned to Class C. (b) A long term use medical device shall be assigned to Class B, if it is intended to be placed into any tooth. (c) A long term use medical de ...

7.5.3.1 Identification The manufacturer shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification. The manufacturer shall establish documented procedures to ensure that medical devices and in vitro diagnostic medical devices returned to the manufacturer are identified and distinguished from conforming pro ...

As a company, we have one of the largest number of briefs on Diagnostics & Medical Devices Regulatory work. We combine this with our in-depth knowledge of drug regulations and help our clients in preparation of pamphlets, brochures, etc. and ensure they are as per the guidelines prescribed by various government departments. Besides this, we also help our clients in preparing dossiers for obtaining ...

Recall Action Commencement Date: The date the recall strategy and communication was agreed by the TGA. vii Responsible Entity: Sponsor / Supplier / Importer responsible for the recall actions. viii Reason / Issue: Reason for the recall action. ix Recall Action: Recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues o ...