Have you heard the one about TGA’s requirements for Medical Device dossiers – they’re stricter now

Clive Simon

Regulatory / Product Development / QA Consultant - Pharmaceuticals and Medical Devices

June 2016

< 1 min reading time

Around the middle of May, I attended TGA’s workshop on Post-marketing requirements for Medical Devices. At this event, TGA reinforced their more stringent dossier criteria for medical devices.

This impacts on all classes of medical devices, particularly Class I and II.

Depending on the situation, TGA may ask for any of the following documents to be supplied within 20 days.
• Declaration of Conformity
• Manufacturer’s evidence of conformity assessment (CE certificate)
• Labels
• IFU
• Promotional material
• Essential Principles Checklist
• Risk Assessment
• Clinical Evaluation Report
• Ingredients and formulations of formulated devices
• Samples if feasible, small and inexpensive item, otherwise wait for TGA to request.

The SPD Company’s recommendation: At the time of including devices on the ARTG, Sponsors like yourself should compile a dossier which contains all of these items above, so it’s ready-to-go should TGA request it.

In addition, TGA can ask for the following to be supplied within 20 days:

• Post-market data incl. supply details, adverse events and complaints
• Technical File documents
• CAPA’s

The SPD Company’s recommendation: As manufacturers must agree to do this, Sponsors like yourself need to draw up a technical agreement with their manufacturers to this effect.

Please contact me directly if you have any questions or would like to know more.

source: https://www.linkedin.com/groups/78665/78665-6153673490714152962

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Posted by Clive Simon

Asked on June 28, 2016 12:00 am

135 views

	Private answer Julie Omohundro Wouldn't most manufacturers already have these documents on hand to support CE marking? Marked as spam Report spam
	Private answer what happens of it goes beyond 20days? Marked as spam Report spam
	Private answer Clive Simon Hi Julie, In Australia the distributor (Sponsor) is treated as a different entity to the manufacturer by the regulatory authority (TGA). To get marketing authorisation for an imported medical device, only a few documents are required. However, if TGA requests more documents from the Technical File, the Sponsor has to get them from the manufacturer. We have instances where it has taken 3 months to get an Australian format declaration of conformity signed by the manufacturer because of their internal processes. Thus we suggest that (a) the Sponsor signs an agreement with the manufacturer that the manufacturer will provide required documents within 20 working days (as required by TGA) (b) Sponsors compile a dossier with the most likely documents that will be required by TGA. I thought this would be of interest to the group because most manufacturers distribute products to Australia, and while Australia is. Small market, it is very sophisticated. Marked as spam Report spam
	Private answer Julie Omohundro Ouch. Having provided regulatory support to distributors, 20 days seemed quite adequate to me. I had no idea that some manufacturers could be that slow in responding to these requests. Marked as spam Report spam
	Private answer Clive Simon Suresh, If it goes beyond 20 days TGA can reject the application. In the few cases where this has happened, we've asked for extensions and this has been granted. We've had to provide a hard date, normally 2 weeks time, when asking for the extension. When we've asked for more than a month this has generally been refused. TGA tend to be cooperative when they understand that the reason for the delay is reasonable. Marked as spam Report spam
	Private answer Clive Simon My experience of these cases are German, US and Japanese companies. The German company had signed an EU DoC and believed this was good enough for Australia (it's not). It took 18 months to convince them to sign it, then work through their hierarchy and change control system. They weren't keen to provide the rest of the required documents The US companies just needed education on the first couple of DoC's and they were good. They needed to be convinced that they had to provide the documents and that involved some discussions, sending TGA guidelines and emails. The Japanese companies were very keen to do the right things and provided excellent support. For some reason we had to work through a few DoC drafts to get it right and there was a lot of to and fro communications. Once they got the first ones right they were great. These were large companies with good systems and strong regulatory teams. The smaller biotechs / medical devices companies tend to be a lot quicker and more flexible. Marked as spam Report spam

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