The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to certificates of free sale and export certificates. The document describes in detail the eligibility criteria and how the interested party may obtain such a certificate. It is important to mention that the provisions of the guidance are not binding. In the case of any contradictions with the provisions of the current legislation, the latter should prevail.
Regulatory Background
The certificates addressed in the present TGA guidance are frequently asked about by the national regulating authorities of the countries to which the medical devices are exported in order to confirm the product in question is allowed to be marketed in and exported from Australia. Such certificates could be issued by the TGA provided that the medical device subject to review is duly registered in the Australian Register of Therapeutic Goods (ARTG), the country’s register of healthcare products allowed for marketing and use.
First, the document outlines the difference between these two types of certificates, namely:
- A certificate of free sale confirms the medical device is allowed to be marketed in Australia; while
- An export certificate could be issued for the products intended to be exported from Australia without permission to make them available on a local market.
Eligibility Criteria
The guidance further describes the particular criteria an interested party shall meet in order to be eligible to apply for any of the certificates described herein.
According to the document, an interested party shall:
- Be the sponsor of the device(s) in question, or be a recognized agent of the product`s sponsor as recorded in the TGA eBS system,
- Have a current inclusion on the ARTG for a kind of medical device that covers the product(s) in question,
- Be exempt under Item 1.2, Part 1, Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002.
As mentioned, a certificate of free sale cannot be issued for a medical device included in the national register as one intended to be exported only. However, export certificates could be issued for medical devices intended to be placed on the domestic market or exported from Australia. Should the product in question be subject to an exemption, the applicant shall provide the appropriate statement indicating the purpose of export and the particular products.
The authority additionally emphasizes that the aforementioned certificates shall comply with the regulatory requirements of the country to which the medical devices are intended to be exported. Thus, the TGA encourages interested parties to contact the appropriate national authorities in advance in order to clarify the applicable requirements for a certificate of free sale or export certificate, as well as the scope of information to be provided with the medical device in general. The Australian authority is unable to advise on regulatory requirements applicable in any other country, so it is the sole responsibility of the interested party to familiarize themselves with such requirements in advance.
Applying for a Certificate of Free Sale or Export Certificate
The basic information an interested party shall provide to the TGA to obtain a certificate of free sale or export certificate shall contain the current ARTG number associated with the medical device in question and the appropriate GMDN codes.
Once issued, a certificate will contain the following details:
- ARTG number(s),
- Device description based on the GMDN code(s),
- GMDN code(s) for medical device,
- The medical device class,
- The sponsor’s name and address,
- The primary manufacturer`s name and address.
In the case of medical devices assigned to Class III under the Australian risk-based classification, the certificate will also contain the indication of a product/trade name.
It is important to mention that if the regulations of the country to which the medical device is intended to be imported require some additional information to be included in a certificate, the interested party may indicate such information when applying for a certificate to the TGA. Such information may include, for instance, details about the kinds of medical devices. In order to apply for the inclusion of additional information in a certificate, the sponsor shall submit the initial application accompanied by the appropriate schedule outlining additional information to be included. These schedules should be issued on the letterhead of the applicant company and submitted in electronic format.
The authority also mentions that when applying for a certificate, the sponsor shall also declare all the details provided relating to medical devices already included in the Australian Register of Therapeutic Goods. All the information included in the application should be accurate and reliable. The submission of an application containing false or misleading information could result in sanctions imposed under the Criminal Code Act 1995.
Additional Aspects
Apart from the points mentioned above, the present TGA guidance also provides additional details regarding particular aspects of the application process.
For instance, it is stated that the application for a certificate of free sale or an export certificate is subject to a special fee to be paid by the applicant. The whole process of issuance will commence only after the sponsor pays the appropriate fee in full.
As mentioned, the application for a certificate should be submitted in electronic form to the appropriate email address. The submission shall consist of:
- A completed application form,
- A schedule containing additional information (if required) that is to be included in your certificate,
- A completed credit card authorization form.
Under the general rule, it should take up to 10 business days for the regulating authority to process the application. However, in certain cases, this timeline could be extended. For instance, this could happen due to the significant volume of the application itself or certain discrepancies between the information provided in the application for a certificate and the appropriate entry in the Australian Register of Therapeutic Goods.
The applicant may choose the way the certificate of free sale or an export certificate is provided. The certificate issued by the TGA could be delivered either by regular mail or in electronic format. The preferred delivery type should be indicated in the initial application form. If paper format is chosen, up to 5 copies could be provided.
The authority also describes cases when the application for a certificate of free sale or an export certificate could be rejected. In particular, this could take place in the following cases:
- The applicant entity is neither sponsor nor its authorized representative/agent. Thus, the application will be rejected on the basis of the ineligibility of the applicant.
- The information included in the application is incorrect.
In both cases listed above, the application fee paid by the applicant will not be refunded.
In summary, the present TGA guidance describes in detail the way a certificate of free sale or an export certificate could be obtained. The TGA also encourages the applicants to contact the regulating authorities in the country of import in advance in order to clarify the applicable regulatory requirements.
Sources:
https://www.tga.gov.au/certificates-free-sale-and-export-certificates-medical-devices
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