Once a product has been released for delivery, the obligations of manufacturers and sponsors do not stop. The device must continue to meet the regulatory, safety and performance requirements required for certification. This requires manufacturers and sponsors to have procedures in place to proactively monitor product performance and take corrective action in the event of an adverse event. In some situations, notification to the control authorities and/or recall of the product may be necessary. Distributors (sponsors) of implantable AIMD, III or IIb products must submit three consecutive annual reports to the TGA as soon as the products are included in the ARTG. The reports must contain all complaints received by the manufacturer regarding problems with the use of the product. This is a mandatory TGA requirement and a prerequisite for the inclusion of artG medical devices that promotes comprehensive post-market surveillance. KD&A helps you develop a compliant post-market monitoring system tailored to your business. Before it can be marketed in Australia, a medical device must first be “included” in the Australian Therapeutic Goods Registry (ARTG).
The application procedure varies according to the type of product, its classification, the place where it is manufactured and whether it has already undergon a conformity assessment. There are various international mutual recognition agreements that can facilitate administrative authorisation. MTC can be your Australian sponsor and take care of and advise on trade agreements in Australia. This application depends on the classification of the product (in accordance with the amended Therapeutic Goods (Medical Device) 2002 regulations) and is subject to the TGA. Setting up your organization as a sponsor at the TGA is part of this process. Start with the delivery of the medical device to the Australian market as soon as an ARTG registration has been reached. Acting TGA Sponsor: Import, Distribution and Business Agreements Ensure that this agreement contains the obligation to provide regulatory documents within 20 days if required by the TGA. Medical devices sold on the European market must bear the CE marking. The CE marking indicates that the product complies with the legislation.
There are several ways to obtain the CE marking. In most cases, manufacturers must have compliance with regulatory requirements assessed by a notified body. . . .