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According to a recent announcement by the Therapeutic Goods Administration (TGA), sponsors of medical devices have a new procedure to follow for certificate of free sale or export certificate. The new application format allows the sponsors to submit their applications and receive the certificates electronically without any hassle and delays. The change in process is in response to the issues faced by the sponsors while notarizing and endorsing certificate of free sale or exports.
The purpose of the electronic procedure is to help device sponsors meet the needs of the importing country as quickly as possible. In this scenario, however, the sponsors are required to contact the importing country to know the specific requirements.
What is a certificate of Free Sale or Export Certificate and Why Is It Needed?
A certificate of sale or export certificate is a document issued by the TGA which indicates that the particular medical device is included in the Australian Register of Therapeutic Goods (ARTG) and can be sold in Australia and exported as well.
Whenever the sponsor try to export the device, the certificate is required by importing country to validate whether the medical device being imported is eligible for import and contains all the important information such as ARTG number, Global Medical Device Nomenclature (GMDN) code, etc.
Eligibility
To be eligible for the certificate, the applicant must meet the following criteria:
- Must be a sponsor of medical device
- Should have an inclusion in ARTG for the kind of medical device in question
- Should be exempted under item 1.2, part 1, schedule 4 of the Therapeutic Goods (Medical Device) Regulations 2002
Limitations
The application may be rejected if any incongruity exists, like:
- If the application is submitted for “export-only” devices
- If there is a mismatch of Global Medical Device Nomenclature (GMDN) codes in your application and that on ARTG certificates
- If you are not a sponsor but an agent in sponsor’s eBS account
The TGA aims to review the applications for Certificate of Free Sale or Export Certificate in approximately 10 business days. However, it may take longer if there are any discrepancies related to the application.
As more health authorities (USFDA, Health Canada) are taking their device application processes through electronic filing systems, manufacturers and sponsors need to have comprehensive understanding of the new procedures and their consequences. In such scenario, an expert in medical device Regulatory affairs and procedures can help to steer through the necessary procedure. Stay up-to-date. Be Informed. Be complaint.
