This application is subject to the classification of the devices (in accordance with the regulations on therapeutic products (medical devices) 2002, as amended, and is subject to the TGA. It also means establishing your organization as a sponsor within the TGA. Start with the delivery of the medical device to the Australian market as soon as an ARTG registration has been reached. Acting TGA Sponsor: MTC import, distribution and business agreements can be your Australian sponsor and support and advise on trade agreements in Australia. Ensure that the agreement contains the obligation to provide administrative documents within 20 days if required by the TGA. Before a medical device can be put on the market in Australia, it must first be included in the Australian Therapeutic Products Registry (ARTG). The application process depends on the nature of the product, its classification, the manufacture in which it is produced and the assessment of compliance. There are a number of international mutual recognition agreements that can facilitate the authorisation of regulatory authorities. This is a mandatory TGA requirement and a condition for medical devices ARTG inclusion, full sponsors post-market monitoring. KD-A helps you develop a compliant post-market monitoring system that is tailored to your business.
Once a product is approved 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 the performance of the device and take corrective action in the event of adverse events. In some cases, it may be necessary to stick to the regulatory authorities and/or recall the product. Distributors (sponsors) of AIMD, CLASS III or Class IIb implantable devices must submit three consecutive annual reports to the TGA as soon as the products are included in the ARTG. Reports must contain all complaints received during manufacturing about problems with the use of the device. As the process defined by URPTG is ongoing and subject to continuous updating, further changes and adaptations are expected so that the recall request by manufacturers and sponsors is clearer and more standardist. .
The MTC can provide advice on the classification of cosmetic products. TCM can also assist in the inclusion of products in the ARTG or in registering with NICNAS. By using MTC services, you can use a whole network of other companies in the medical device industry. The medical device industry is highly regulated and affects almost every facet of the design, manufacturing, distribution and advertising business. One of the key factors in the success of each medical company is to ensure that all employees are trained in the impact of regulation on their work. MTC has more than 60 years of experience in the medical technology industry and has established a network of contacts and business partners during this period. MTC can help you navigate the complexity of regulatory approvals for all international markets. Make sure you receive a copy of the manufacturer`s CE marking certificate and basic information about the device.