Manufacturers' evidence - EC certificates for medical devices
Fact sheet no. 17
October 2006
1. What is manufacturers' evidence?
Manufacturers' evidence is a certificate that demonstrates a manufacturer has been assessed (audited) and has the appropriate quality management system to manufacture medical devices at that site.
The manufacturer may have a variety of different certificates, however the certificates the TGA accepts as manufacturer's evidence are: European Union European Community Certificates (EC), TGA Conformity Assessment Certificates and Mutual Recognition Agreement (MRA) certificates.
Note: A certificate from the Food and Drug Administration (FDA) is not acceptable because it has been issued against a different auditing criteria to that required under the Australian legislation.
An International Standards Organisation (ISO) 13485 compliance certificate is not acceptable because does not provide assurance that the requirements of the Australian Regulations have been taken into consideration.
2. Who is responsible for obtaining and updating the manufacturers' evidence?
The manufacturer is responsible for obtaining and ensuring the information on the European Community certificate (or the TGA Conformity Assessment Certificate) is current and valid (eg. the scope of devices manufactured at the site, expiry date etc).
The Australian sponsor is responsible for obtaining an original or properly notarised copy of the certificate from the manufacturer, submitting the evidence to the TGA for assessment, and ensuring the certification always remains valid while the device is supplied in Australia.
Note: If a certificate submitted as Manufacturer Evidence passes its expiry date the medical devices in relation to this certificate may be cancelled from the Australian Register of Therapeutic Goods (ARTG). The sponsor must ensure that the certificate remains valid.
3. What happens if my manufacturer does not have a European Community certificate?
If the manufacturer does not have a European Union European Community certificate the manufacturer should in first instance apply for a European Community certificate from an European Union Notified Body. If this is not possible, the manufacturer could apply to the TGA for a Conformity Assessment Certificate and undergo conformity assessment by the TGA.
4. Determining if a certificate is acceptable
The TGA will make the final determination as to whether the certificate is acceptable. However there are some details on the certificate that can be checked before submitting to the TGA. These details are described on the following pages titled Details to look for on an EC certificate.
For further assistance regarding manufacturers' evidence please refer to the guidance document "Conformity Assessment Procedures" <http://www.tga.gov.au/docs/html/devguid3.htm>.
5. Submitting a European Community certificate to the TGA
Submissions for clearance of manufacturers' evidence are received electronically through the Device Electronic Application Lodgement (DEAL) system. Access to most areas of this electronic business site is restricted by password. New users to the device electronic application lodgement system can establish an electronic business account at the Strategic Information Management Environment (SIME) homepage. http://www.tgasime.health.gov.au/SIME/home.nsf
To register the manufacturers' evidence, select Register a manufacturers' Evidence on the device electronic application lodgement (DEAL) front page and follow the prompts.
6. Is there an appliation fee?
There is no fee for submitting manufacturers' evidence.
Details to look for on an EC certificate
Note: This is an example only. Wording and formatting will vary between notified bodies
Annex to certificate
How to decide which is the appropriate European Community certificate for the Class of the device
Below is a table which explains the appropriate European Union Device Directive and Annex for each class of device.
| Classification | Option 1 | Option 2 | Option 3 | Option 4 | Directive |
|---|---|---|---|---|---|
| Class 1 Measure | Annex II.3 | Annex V | Annex IV* | Annex VI | 93/42/EEC |
| Class 1 Sterile | Annex II.3 | Annex V | n/a | n/a | 93/42/EEC |
| Class IIa | Annex II.3 | Annex V | Annex IV* | Annex VIT | 93/42/EEC |
| Class IIb | Annex II.3 | Annex V + III | Annex IV + III* | Annex VI + IIIT | 93/42/EEC |
| Class III | Annex II.3 + 11.4 | Annex V + III | Annex IV + III* | Annex VI + IIIT | 93/42/EEC |
| AIMD | Annex 2.3 + 2.4 | Annex 5 + 3 | n/a | n/a | 90/385/EEC |
| T Indicates that this option may only be used if the device is supplied non-sterile. * Indicates that this option may only be used if the device is supplied non-sterile and only 1 batch is included in the certificate. |
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Disclaimer
This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.
© Commonwealth of Australia 2006