In order to export medical device products to Australia, in addition to the need for TGA certification, you also need to find a local agent, also called TGA Sponsor, by the Sponsor to complete the registration of medical devices, and then the product can be sold in the Australian market.
According to the Australian Medical Goods Act (Therapeutic Goods Act1989), all medical supplies (drugs and medical devices) listed in Australia must be registered or registered with the Australian Medical Supplies Administration (TGA) in accordance with the relevant requirements. The Australian Register of Therapeutic Goods (ARTG) can only be legally listed.
一、What are the duties of an Australian TGA agent?
1. Register the manufacturer's medical devices and IVDs with the TGA prior to commercial sale
2. Act as the liaison between the manufacturer and TGA to handle equipment complaints, adverse events and recalls
3. Provide information and documentation about the equipment as required by the TGA, with the written permission of the manufacturer
4. Provide the name and contact information of the Australian TGA agent required for product packaging, label and instruction manual
二、Can choose a dealer as a TGA Sponsor in Australia?
1. Australian TGA agents may provide confidential design and testing information about medical devices when required by the TGA. Manufacturers prefer to provide this information to an independent company (rather than a distributor) to protect their intellectual property.
2. The TGA medical device registration application process is complicated and requires frequent communication between regulatory officials and industry agents. Dealers may not have the resources or expertise needed to address the complexities of the registration process.
3. Australian TGA agents play an important role in post-marketing vigilance, in the event of recalls, adverse events, etc., agents need to assist manufacturers in determining response strategies. The dealer may not have the relevant experience or even have a conflict of interest with the manufacturer.
4. In the event of a change in Australia's medical device regulations, TGA Sponsor should be able to keep abreast of the change in its responsibilities and inform manufacturers of any new regulations affecting medical devices.
三、Summary of common problems of TGA in Australia
1. Can Sponsor be a customer? What's the difference between it and a third party?
Sponsor can be an Australian customer. Since the Sponsor needs to complete the registration, the registration number is required at the time of customs clearance, and TGA registration is likely to be required when the Chinese manufacturer develops a new customer in Australia. When a Chinese manufacturer entrusts a third-party organization as a Sponsor, duplicate registration can be avoided.
2. Does TGA registration need to be renewed annually? When do I need to update?
TGA registration needs to be renewed annually, and the renewal time is at the end of June each year.
3. Does TGA registration require an on-site review?
For the relatively high risk level, it is usually understood that the same device in Europe requires the participation of the notified body category, and the product has not obtained the CE certificate, the TGA will conduct on-site review.
4. Is MDSAP required for Australian registration?
Australia is one of the five countries that initiated MDSAP, which is not currently required for TGA registration.
5. Is CE certification required for Australian registration?
CE certification is not required. For medium - and high-risk medical devices, obtaining a CE certificate will obviously greatly reduce the cycle time and cost of obtaining a TGA registration.
6. Is there an official fee for TGA registration?
It is payable annually according to the risk category of the product.
7. Can a company designate multiple sponsors?
Enterprises can specify multiple sponsors.
8. Will I get a certificate after TGA registration?
A TGA certificate will be issued upon successful registration.
9. Can TGA be queried on the public website after registration?
After TGA registration is completed, it can be queried in TGA's ARTG database.
