Regulatory Open Forum

Good morning,

i'm an italian regulatory consultant in teh medical device field.

I would like to know if there are some regulatory requirements which requires direct and commercial contact between the manufacturer outside Australia and the australian Sponsor.

If so, Can you  please the regulatory reference (e.g., 'Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 Act n. ???)

Thank you very much

Caterina, there would need to be a commercial contract between the manufacturer and the Australian sponsor but that is not a requirement of the TGA. The only other on is the Post market responsibilities for manufacturers and sponsors of medical devices. I have attached a link to the TGA guidance document which sets out all the information you need.

.https://www.tga.gov.au/sites/default/files/2023-03/post-market-responsibilities-for-manufacturers-and-sponsors-of-medical-devices.pdf 

Regards

Good morning,

i'm an italian regulatory consultant in teh medical device field.

I would like to know if there are some regulatory requirements which requires direct and commercial contact between the manufacturer outside Australia and the australian Sponsor.

If so, Can you  please the regulatory reference (e.g., 'Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 Act n. ???)

Thank you very much

Good morning,

i'm an italian regulatory consultant in teh medical device field.

I would like to know if there are some regulatory requirements which requires direct and commercial contact between the manufacturer outside Australia and the australian Sponsor.

If so, Can you  please the regulatory reference (e.g., 'Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 Act n. ???)

Thank you very much

When making an application for inclusion of a device the applicant must certify that they have sufficient information to demonstrate compliance or have procedures in place, including a written agreement in place with the manufacturer that such information can be obtained with in a designated time (Therapeutic Goods Act 1989 Section 41FD).  The regulations allow for these procedures/agreements to be requested by the agency.  Not a requirement to be a commercial contract, but without a commercial agreement in place first why would a manufacturer establish such procedures (can end up a lot of work for no financial benefit).

It's not necessary that the agreement/procedures are directly in place with the manufacturer and it is not uncommon to have a series of agreements in place.  How well this works in practice depends on the level of understanding each party has of the whole series and how they are supposed to work together.

I'd agree with Richard that a Sponsor should be considered a critical supplier, or clearly documented why they do not need to be classed as such.

Good morning,

i'm an italian regulatory consultant in teh medical device field.

I would like to know if there are some regulatory requirements which requires direct and commercial contact between the manufacturer outside Australia and the australian Sponsor.

If so, Can you  please the regulatory reference (e.g., 'Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 Act n. ???)

Thank you very much