Abridged assessments for medical devices previously registered or listed in the Australian Register of Therapeutic Goods (ARTG)
Information document No. 34
Background
In October 2002 the TGA introduced a new regulatory system for medical devices, with a five year transition period for devices supplied in Australia at the time of implementation of the new system. As from 4 October 2007, medical devices currently Registered or Listed in the ARTG must be "Included" in the ARTG. There is no "automatic" transition - sponsors must apply for inclusion and the devices must have been assessed as complying with the requirements of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
There is no exact correlation between the existing Listings and Registrations and the resulting Inclusions of the product as a "kind of medical device" (section 41BE of the Therapeutic Goods Act 1989). Most currently Registered Devices will, when classified in accordance with the new system, result in Class III/AIMD (Active Implantable Medical Device). inclusions (highest risk classes) whilst Listed devices may translate to classification at any level from Class I to Class III or AIMD.
Under the Regulations, Class III/AIMD devices CE certified by a European Notified Body are subjected to an audit of the application to ensure that an appropriate assessment has been carried out. During this Application Audit process, the TGA requests and reviews essential information originating from both the EU Notified Body and the device manufacturer.
Application audits may be at two levels of depth:
- Level 1 which consists of the review of the manufacturer's Declaration of Conformity, original certificates and product information.
- Level 2 which require, in addition to the above, more detailed information on the assessment of design and the implementation of the quality system.
Although for most Class III and AIMD devices the documentation relating to the European assessment process is accepted as a basis for inclusion on the ARTG, the legislation requires that devices manufactured in Australia or containing medicinal substances or materials of animal, microbial or recombinant origin must obtain a Conformity Assessment Certificate from the TGA before an application for Inclusion can be submitted.
The TGA also accepts medical devices certification issued under the Mutual Recognition Agreement between Australia and the EU (MRA). This applies to EU manufacturers only, does not extend to some high risk devices that are currently excluded, and only a subset of Notified Bodies are designated. Applications submitted under MRA certifications are not subject to Application Audits.
This document is intended to describe the levels of assessment which may be applied to medical devices which are currently registered or listed and for which the inclusion process may be abridged based on the information already available to support the compliance of the devices with the new regulatory system.
Abridgement process
In recognition that many sponsors are required to create Inclusions for products that have been already evaluated by the TGA under Part 3 of the Therapeutic Goods Act 1989 (the old legislation), the TGA is prepared to conduct abridged assessments if the sponsor holds a current Registration for such product. Listed products provide no grounds for abridgement under the current regulatory system for medical devices since the TGA evaluation of those devices under the old legislation was limited.
Table 1 provides an overview of the assessment required for the Inclusion of Class III/AIMD devices that are currently registered or listed in the ARTG:
- Class III/AIMD devices.
Assuming b), c), d) or e) below is not applicable. - Class III devices that are a lower class in the EU and CE certified at a lower level.
Assuming c), d) or e) below is not applicable. - Class III/AIMD devices that contain medicinal substances.
- Class III/AIMD devices that contain materials of animal, microbial or recombinant origin.
- Class III/AIMD devices manufactured in Australia.
In addition, the level of assessment required depends on whether the manufacturer and/or the medical device have been CE certificated in the EU by a Notified Body. This is reflected in the left and right main columns in Table 1.
The last right column in Table 1 specifies the level of assessment for listed products which are not CE certified by an EU Notified Body. This is the level of assessment applicable to a new product (a full assessment).
For Class III/AIMD devices registered in the ARTG before 4th October 2000 and also CE certified by an EU Notified Body, the TGA requires from the manufacturer a "Summary of Post Market Surveillance".
A report on post market surveillance may include but is not limited to:
- an outline of activities undertaken by the manufacturer to monitor the quality, safety and performance of the device since the time of marketing, for example how complaints and adverse incidents are handled and investigated, review of results of post market clinical trials, review of literature and how has benefit-risk been assessed on an ongoing basis;
- a summary of the results and conclusions arising from by those activities, including discussion of the severity and causality of adverse incidents;
- an assessment of the significance of the results, in particular. which issues, if any have led to changes to product information or instructions for use (e.g. safety related changes such additional warnings, restriction of patient populations) or regulatory action; and
- identification and discussion of recalls, hazard alerts etc and any other regulatory action.
To give context to conclusions reached about the safety of the product, an attempt should be made to provide an estimate of the denominator and, consequently, the incidence of any adverse outcomes. Furthermore, the report should cover all markets, not just Australia. This will allow more comprehensive data to be used and more precise estimates of the incidence of events.
NOTE:
Class III/AIMD devices for which a Conformity Assessment Certificate is issued by the TGA are not subjected to an Application Audit at the time of Inclusion in the ARTG.
Table 1
| Product | Product CE certified by an EU Notified Body | Product not CE certified | ||
|---|---|---|---|---|
| Registered (*) | Listed | Registered (*) | Listed | |
| a) Class III/AIMD devices which are not manufactured in Australia, do not contain materials of animal, microbial or recombinant origin and do not contain medicinal substances. |
Application Audit Level 1 Application Audit Level 1 including review of Summary of Post Market Surveillance |
Application Audit Level 2. |
Manufacturer obtains CE certificates + See column 1. OR Manufacturer obtains MRA certificates (if eligible) OR Manufacturer obtains Conformity Assessment Certificates. Examination of Design abridged on the basis of previous registration. |
Manufacturer obtains CE certificates + See column 2. OR Manufacturer obtains MRA certificates (if eligible) OR The manufacturer obtains Conformity Assessment Certificates. Full assessment. |
| b) Class III devices that are a lower class in the EU and CE certified at a lower level. |
Manufacturer obtains CE certificates for Class III device + See Table 1(a). OR Manufacturer obtains MRA certificates (if eligible) OR Manufacturer obtains TGA Conformity Assessment Certificates. Quality system assessment abridged of the basis of EU Notified Body audit reports. + Examination of Design abridged using previous registration. |
Manufacturer obtains CE certificates for Class III device + See Table 1(a). OR Manufacturer obtains MRA certificates (if eligible) OR Manufacturer obtains TGA Conformity Assessment Certificates. Quality system assessment abridged of the basis of EU Notified Body audit reports. + Full Examination of Design. |
Not applicable | Not applicable |
| c) Class III/AIMD devices that contain medicinal substances |
Manufacturer obtains TGA Conformity Assessment Certificates. Medicinal quality, safety and efficacy assessment (unless done previously). + Quality system assessment may be abridged of the basis of EU Notified Body audit reports - subject to consideration by the TGA. + Examination of Design abridged using previous registration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Medicinal quality, safety and efficacy assessment (unless done previously). + Quality system assessment may be abridged of the basis of EU Notified Body audit reports - subject to consideration by the TGA. + Examination of Design may be abridged using EU Notified Body design/type examination reports - subject to TGA consideration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Medicinal quality, safety and efficacy assessment (unless done previously). + Full quality system assessment + Examination of Design abridged using previous registration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Medicinal quality, safety and efficacy assessment (unless done previously). + Full quality system assessment + Full Examination of Design. |
| d) Class III/AIMD devices that contain materials of animal, microbial or recombinant origin |
Manufacturer obtains TGA Conformity Assessment Certificates. Assessment of material safety including implementation of CASO No 2. + Quality system assessment may be abridged using EU Notified Body audit reports - subject to TGA consideration. + Examination of Design abridged using previous registration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Assessment of material safety including implementation of CASO No 2. + Quality system assessment may be abridged using EU Notified Body audit reports - subject to TGA consideration. + Examination of Design may be abridged using EU Notified Body design/type examination reports - subject to TGA consideration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Assessment of material safety including implementation of CASO No 2. + Full quality system assessment + Examination of Design abridged using previous registration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Assessment of material safety including implementation of CASO No 2. + Full quality system assessment + Full Examination of Design. |
| e) Class III/AIMD devices manufactured in Australia |
Manufacturer obtains TGA Conformity Assessment Certificates. Quality system assessment may be abridged using EU Notified Body audit reports - subject to TGA consideration. + Examination of Design may be abridged using EU Notified Body design/type examination reports - subject to TGA consideration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Quality system assessment may be abridged using EU Notified Body audit reports - subject to TGA consideration. + Examination of Design may be abridged using EU Notified Body design/type examination reports - subject to TGA consideration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Full quality system assessment + Examination of Design abridged using previous registration. |
Manufacturer obtains TGA Conformity Assessment Certificates. Full quality system assessment + Full Examination of Design. |
(*) Products registered under the same sponsorship.