The new article provides additional details on the application process to be followed by the entities interested in designation as conformity assessment bodies, as well as the assessment process associated thereto.
Table of content
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to determinations for Australian conformity assessment bodies. The document provides a general overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Application and Determination Process
According to the guidance, the initial determination of the Australian conformity assessment body (CAB) is valid for four years, during which the TGA monitors their performance. Specific guidelines have been published by the authority outline the requirements for Australian CABs after a determination is made and the ongoing monitoring activities by the TGA.
For detailed requirements related to monitoring, the document refers to Part 4A of the Medical Devices (MD) Regulations.
Pre-Application Meetings
As explained by the TGA, before applying, companies are encouraged to arrange a pre-application meeting to discuss:
- Requirements for a determination
- The assessment process
- Obligations of Australian CAB employees
In order to request the pre-application meeting, an interested party should contact the authority via email.
Application Process
The guidance further describes in detail the application process to be followed when applying for a CAB designation under the existing legal framework.
Before starting an application, a TGA Client ID is needed. For this purpose, the applicant should complete the Organization Details form to get a Client ID, selecting “Agent” as the organization role and identifying the organization as a potential Australian CAB.
The online application form must be used, and it should be completed in one session using Microsoft Edge or Google Chrome.
The form consists of seven sections:
- Introduction: Provides an overview of the application form and key term definitions.
- Applicant Information: Collects details such as TGA Client ID, eligibility assessment information, and primary contact details.
- Organizational Structure: Details the applicant’s organizational structure, including relationships with larger/parent organizations and subsidiaries.
- Scope of Conformity Assessment: Requires information on the proposed scope of conformity assessment procedures and medical devices.
- Supporting Information: Requires submission of supporting documents.
- Declaration: Requires a declaration before submission.
- Confirmation: Displays a confirmation message and sends a notification email upon successful submission.
When submitting the form, the following documents must be provided as well:
- Legal status evidence of the Australian corporation and date obtained
- Legal status evidence for entities identified in Section 3
- Proof of adequate general liability insurance
- A brief company history
- Function and operational unit chart
- Evidence of recognition as an MDSAP AO, if applicable
- Designation report under EU 2017/745 and/or EU 2017/746 for relevant entities
The application should be accompanied with the declaration whereby the applicant undertakes to comply with Australian requirements and accept that additional non-standard conditions may be imposed.
Post-Submission
After submitting the application, a notification email with an application ID number and next steps information will be sent to the applicant. It is important to mention that the application fee should be paid only after receiving an invoice.
The review will commence only once the form, supporting documents, and fee are received.
Fees and Charges
Application and assessment fees vary based on the scope of the request. Payment can be made by credit card or electronic funds transfer (EFT), and fees should not be paid until an invoice is received.
Initial Application Review
When commencing the review, the authority would decide on:
- Scope of the determination request
- Completeness of supporting information provided by the applicant
- Eligibility of the applicant in general
Request for Additional Information
The TGA will provide a supporting information checklist, referencing specific documents to show how requirements for an Australian CAB determination are met, including:
- Regulation 4A.6(3) declaration
- Statutory conditions for every determination
- Annex VII of the European Medical Devices Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, as modified by Schedule 3AA
Assessment
After receiving all documents and paying the assessment fee, the TGA will assess:
- Procedures and records for compliance with determination criteria
- Implementation and effectiveness of the applicant’s Quality Management System (QMS)
Under the general rule, assessment activities may include offsite, onsite, or remote evaluations, including head office and critical locations where key functions are carried out.
Witnessing of Audits or Design Examinations
Under the general rule, the TGA may witness QMS audits or design examinations. Written agreements with the manufacturing facility are required to allow TGA observation or use of audit documentation for regulatory purposes.
Assessment fees include costs for witnessing these activities.
Determination Decision
The Secretary’s delegate will make a decision if all conditions are met, including:
- Satisfactory completion of the Annex VII assessment
- Addressing any identified non-conformities
- Completion of the Regulation 4A.6(3) declaration
- Full payment of the assessment fee
In addition to the above, a self-assessment of criteria set out in sub-regulation 4A.6(3) is required, with a signed statutory declaration submitted by a senior, authorized individual in the corporation.
Next Steps
The TGA will publish the determination on the Register of Australian CABs. Australian CABs and subcontractors will be monitored annually to ensure ongoing compliance with regulatory requirements.
As set forth under the applicable regulatory requirements, re-determination assessments occur every four years.
Conclusion
In summary, the present TGA guidance provides a detailed overview of the regulatory requirements for the designation of conformity assessment bodies under the existing legal framework. The document outlines the key points to be taken into consideration by the entities interested in designation in order to facilitate and streamline the process.
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