The new article describes some aspects related to the information accompanying the products.
It provides additional clarifications regarding the parties’ obligations as set forth under the existing legal framework.
Table of content
The Therapeutic Good Administration (TGA), an Australian regulating authority in healthcare products, has published a guidance document dedicated to the medical device systems and procedures packs intended to be marketed and used in the country.
The document provides an overview of the applicable regulatory requirements and additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with them.
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, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Instructions for Use (IFU)
According to the guidance, the declaration made under clause 7.5 by the SOPP manufacturer requires the inclusion of instructions for use (IFU) for each item within the SOPP, as provided by their respective manufacturers.
Essential Principle (EP) 13.4 details the requirement for medical devices to come with IFU, except for specific device classes that can be safely used without them.
Specifically, EP 13.4(3) outlines the necessity of including comprehensive information in the IFU to ensure users can identify the device or its contents correctly.
It is essential to mention that modifications to the original IFU by the SOPP manufacturer place the responsibility of conformity assessment on them for the modified component.
Electronic IFU (eIFU) Provision
The regulations also allow using electronic formats for IFU, especially for devices intended for professional users.
This flexibility allows for online or other electronic means of IFU distribution, with specific guidance for implantable medical devices aimed at professional use, where a printed document directs users to access the eIFU online.
Patient Information Materials
As explained by the authority, starting 1 December 2021, all implantable medical devices must include patient implant cards and patient information leaflets, as detailed in EP 13A.
This requirement ensures that patients receive essential information about the implantable devices.
Furthermore, from 29 October 2021, there will be greater flexibility in how this information is provided, allowing for the electronic distribution of patient information materials and enhancing accessibility for patients.
Obligations for SOPP Manufacturers
The document describes in detail the obligations of manufacturers. In particular, significant changes effective from 25 November 2021 impact SOPP manufacturers, especially those utilizing the specific conformity assessment procedure.
These changes necessitate manufacturers to comply with updated declaration requirements, emphasizing the need for conformity assessment documents and proper documentation of IFU modifications.
Manufacturers should also ensure compliance with regulations regarding the design, production, packaging, and labeling of medical devices, including those assembled, processed, or refurbished using ready-made products.
Obligations for SOPP Sponsors
Under the general rule, sponsors are responsible for importing, supplying, and exporting medical devices in Australia, including SOPPs.
Their duties include, among other things, ensuring compliance with essential principles, obtaining and maintaining appropriate market authorization, adhering to labeling standards, and fulfilling post-market obligations.
For SOPPs supplied under the particular conformity assessment procedure, sponsors should follow transition arrangements and meet new regulatory requirements post-25 November 2021, ensuring SOPPs are included in the ARTG based on updated conformity declarations.
Transition Arrangements
The transition above arrangements offer a grace period for SOPPs already included in the ARTG or pending ARTG inclusion as of 25 November 2021.
These SOPPs may continue to be supplied without meeting the new requirements until 25 November 2025. After this period, updated manufacturer evidence must support the ARTG entry to comply with the new requirements.
Conclusion
In summary, the present document outlines the critical aspects of regulatory compliance for SOPP manufacturers and sponsors, focusing on instructions for use, patient information materials, and the obligations of both manufacturers and sponsors. With the introduction of electronic options for IFU and patient information materials, the regulations offer flexibility while ensuring patient safety and informed use of medical devices.
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