The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to completing applications for consent to import, supply, or export medical devices that are not compliant with the applicable Essential Principles. The document describes in detail the application form to be submitted and also specifies the particular information to be provided therein. Recommendations and clarifications provided in the guidance are intended to assist medical device manufacturers and other parties interested in obtaining consent for specific operations about medical devices they are responsible for.
According to the guidance, the form requires specific details regarding the applicant entity, as well as about an authorized person who is submitting the form. The information to be provided should include, inter alia, the following details:
- Information about the submitter (authorized person), including his/her name and surname.
- TBS Client ID Number – the appropriate number used to access the TGA electronic business system used for submissions.
- Contact email of the submitter.
- Indication of the position of the applicant concerning the medical device in question (e.g., sponsor, manufacturer, or agent).
- Detailed information about the sponsor, including its address and contact details.
- Indication of the particular operation for which the consent of the authority is needed (e.g., importing, exporting, or supplying a medical device that is not compliant with the Essential Principles).
- Reference numbers of ARTG entries / Applications for Inclusion. This section refers to the numbers assigned to medical devices when information about them is submitted to the Australian Register of Therapeutic Goods (ARTG) – under the general rule, any medical devices should be included in ARTG to be allowed for marketing and use in Australia. Depending on the regulatory status of the medical device in question, it could be either an ARTG entry number, if the product has been already included in the register, or the appropriate application number, if the inclusion is still in process. The application could refer to a maximum of 20 entries. Should the applicant require more, several forms should be submitted. However, all such forms would be considered as parts of the same application.
Information on Non-Compliance to the Essential Principles
The most important information to be provided by the applicant entity refers to the particular deviations from the requirements set forth by the Essential Principles. This information is necessary for the authority to be able to assess whether the product in question should be allowed for marketing and use in the country. The authority explicitly states that all the fields in this section are mandatory.
According to the guidance, the applicant should specify the particular Essential Principles that apply to the product subject to review, but with which the product fails to comply. Moreover, the applicant should also duly justify the reasons for non-compliance, and outline the risks resulting from this.
To provide the information outlined hereinabove, the submitter should complete the following steps:
- Select the relevant Essential Principles or parts of an Essential Principle for which consent is requested.
- Describe how the device(s) do not conform to this/these selected Essential Principle(s).
- Indicate whether the changes in the regulations are a contributing factor for the non-compliance to the Essential Principles.
- Provide additional details on the risks associated with the non-conformance, if the non-conforming device(s) were to be imported, exported, or supplied.
ARTG / Application for Inclusion
As it was mentioned before, the applicant would also have to provide references to the respective ARTG entries or Applications for Inclusion in the ARTG, depending on the current regulatory status of the products in question. In particular, it would be necessary to provide the following details:
- ARTG entry or Application for Inclusion number. Depending on the current status, the applicant should tick the applicable option and indicate the number.
- Proposed duration of the consent to supply for this ARTG/Application for Inclusion. The applicant should also specify the particular period for which the consent to import, supply, or export non-compliant devices is needed. For this purpose, the applicable start and end dates should be indicated. Under the general rule, this refers to a period needed to achieve compliance with the applicable regulatory requirements. It is also important to mention that the appropriate justification should be provided as well.
- Batches affected. According to the guidance, there is an option to apply for consent only for specific batches of the product. Should it be the case, the applicant should indicate respective batches and justify.
- Information of estimated stock levels. If consent is needed for specific batches, i.e., for a limited number of medical devices, this should be reflected accordingly. Furthermore, the applicant should also indicate whether a supply shortage could occur in case the requested consent would not be granted.
- Any additional impact(s) to Australian consumers if the consent is not approved. The applicant will also have an option to provide additional information regarding the way the absence of consent could potentially impact consumers. For instance, in this section, the applicant may indicate that there are no other devices of this kind included in the ARTG, or that this device is for a particular patient group.
- Strategy to mitigate non-conformance for ARTG/Application for Inclusion. In this section, the applicant should provide detailed information about the specific measures to be taken to mitigate non-compliance with the applicable Essential Principles the device should be compliant with. The scope of information to be provided in this section depends on the particular non-compliances. The applicant would also have to submit an implementation plan, which should describe the actions to be taken.
Adding Another Entry
As it was mentioned before, the system allows indicating more than one product within the scope of a single application for consent. In particular, the applicant may indicate up to 20 ARTG / Applications for Inclusion within a single form. There is also an option to replicate the information provided before, which allows facilitating the submission since some of the data fields could require identical information. Thus, the submitter would have an option to either replicate the information entered previously or to enter new details.
In summary, the present TGA guidance outlines the scope of information to be submitted by an interested party applying for consent to supply non-compliant products concerning details of the applicant entity and the products in question. The document provides additional clarifications regarding the form to be submitted and the way it should be filled in.
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