Australian Registration of a CE Marked Medical Device

[dionysisf]

Hello,

We are a medical device company and we are producing Class IIb infusion pumps which are CE marked.
We are interested to Australian market and after a quick search we found that "There is a Mutual Recognition Agreement between Australia and Europe recognising each other countries conformity assessment. In other words, you need to have the EC certificate, an Australian-based sponsor and you can apply.

But, as shown in page 138 of the ARGMD (https://www.tga.gov.au/pdf/devices-argmd-01.pdf), "The TGA does not currently accept MRA certificates for the following devices, as confidence-building arrangements have not occurred:
? powered drug-infusion pumps."

Is it correct? What is the additional process?

Best regards,
Dion

 

[Ronen E]

Hello,

We are a medical device company and we are producing Class IIb infusion pumps which are CE marked.
We are interested to Australian market and after a quick search we found that "There is a Mutual Recognition Agreement between Australia and Europe recognising each other countries conformity assessment. In other words, you need to have the EC certificate, an Australian-based sponsor and you can apply.

But, as shown in page 138 of the ARGMD (https://www.tga.gov.au/pdf/devices-argmd-01.pdf), "The TGA does not currently accept MRA certificates for the following devices, as confidence-building arrangements have not occurred:
• powered drug-infusion pumps."

Is it correct? What is the additional process?

Best regards,
Dion

Hi Dion,

A few notes:

- Please note that the most current revision of the ARGMD is already quite old - it was issued May 2011.

- The MRA was amended on 1.1.2013. "Powered drug-infusion pumps" are not specifically listed in the amended MRA as medical devices which the current confidence-building process applies to. However, active implantable devices and class III devices are, so you might want to be sure your device doesn't fall in these categories. The current confidence-building phase was intended to be 2-years long, i.e. it is due for review 1.1.2015.

- The MRA provisions apply only to medical devices manufactured in the EC or Australia, i.e. if the device is not manufactured in the EC then the fact that it is CE marked is not enough. Please note that for the MRA purposes the following activities are excluded from the term "manufacturing": repairing, reconditioning, refurbishment, labelling, packaging, quality control inspections alone, or sterilisation alone. That means that performance of one or more of these activities outside the EC and Australia doesn't exclude the subject devices from the MRA scope.

- In cases where the MRA doesn't apply, but the devices are already cleared under the MDD (an EC certificate is available), the devices can typically be cleared by the TGA rather painlessly through the "ordinary" CE-marked route.

Cheers,
Ronen.

 

[medwise]

Hi dionysisf -

Let me simplify the TGA registration process for you -

The TGA registration is a two stage process and involves:

Stage 1: online lodgement of the manufacturer?s evidence (EC Certificate) with the TGA. Timeline 2-4 weeks.

Stage 2: online lodgement of the actual medical device applications. For Class IIa and IIb - approval will take 2-4 weeks from submission.


When approved by the TGA, the Soponsor will be issued with an ARTG (Australian Register of Therapeutic Goods) number and certificate for each application. https://www.tga.gov.au/industry/devices-basics.htm

Audit Requirements:

The TGA conducts both pre and post market audits of applications i.e. before and after approval. If audited before approval, the application time may extend by at least 2-4 months.

Product Information/Documentation Requirements:

To enable an Australian Sponsor to register medical devices in Australia, the following documentation and details need to be supplied by the manufacturer:

• List of the products to be supplied
• EU MDD Class of each product and Classification rule used
• CE Certificate for each product (please specify which certificate is for which product to avoid confusion)
• Is each product sterile?
• Is each product single use?
• Is each product an ?active medical device??
• Is each product ?invasive??
• Is each product ?measuring??
• GMDN code for each product - The GMDN (Global Medical Device Nomenclature) is an Australian requirement, if these are not known Sponsor should be able to assist ? these are not necessarily the same as the UMDNS.
• Labels
• Instructions for Use (IFU)/ User Guide of all products
• Advertising Brochure if present for any device.
• Australian Declaration of Conformity (DoC) ? templates for the DoC?s will be provided based on the classification and EC Certification of the products. Some important aspects of the DoC are compliance to the Essential Principles, the class of the device, the GMDN, and the EC Certificate covering the products.

Keeps us posted on how you went. All the best!