Medsafe, New Zealand

 

Medsafe (New Zealand Medicines and Medical Devices Safely Authority) is the NZ equivalent to Australia’s TGA, though it operates differently to the TGA.

Overseas manufacturers looking to sell products in Australia should look at NZ as well.  With a population close to 5m people, it is equivalent in size to NSW and Victoria in Australia.  

To sell products in NZ, the manufacturer needs to register a Sponsor with Medsafe.  RSA has a registered office in Auckland and we can act as your NZ sponsor.

Why Use RSA as Your Medsafe Sponsor?

RSA is different to most other sponsors.   We are not primarily a technical regulatory consultant, although we offer those services too.   We are not a distributor, though we can help you find the right distributor.  We have no conflict of interest.  We are not based internationally.  Although we are Australians, living and mainly working in Sydney, we have an office in NZ and have a close association with NZ companies, regulators and government.

Above all, we are business people focussed on making sure you get accurate and impartial advice to help you make the right decisions to give your product(s) and your business the best chance of succeeding. 

If you don’t know whether it is worth selling in New Zealand, we can help you with market analyses and market intelligence.  We help clients find distributors or, if they are selling direct, help them find contacts with potential customers.

If you want to sell in New Zealand, the first piece of advice you will need is how best to structure your NZ enterprise to make it profitable and minimise the cost of selling in Australia.  Do you need to set up a company?  Do you need to register your (foreign) company in NZ? Or can you get by with just having a Sponsor in NZ?  Are your product(s) regulated by the Medsafe, do they fall within another NZ regulatory regime or can you sell in Australia without registering your products?

We can guide you through those considerations and explain the options available to you.

You may need a regulatory consultant to help you deal with technical queries with Mesafe.  Many of our clients come to us through a regulatory consultant who has recommended us.  We work with many regulatory consultants across Australia.  If you don’t have one, we will recommend one or more consultant for you to speak to, based on your product(s) and their expertise. 

You may also need to find a distributor, or you have sales channels already organised and need importing, warehousing and despatching services.  We can help you in these areas as well.

If your best option is to establish a legal presence in New Zealand, we can help you all the way.  We can create a company for you, which will become the Medsafe Sponsor.  It needs an Australian or a New Zealander as a director.  We can provide that person.  

We’ll help you with accounting, tax and company secretarial services.  More than that, we can help with strategy, local management, business development, marketing, sales, recruitment and operations assistance.  That’s where RSA stands out from others – we have been CEO’s of businesses doing all those things.  We understand how to bring it all together to make it easy for you, as a foreign manufacturer, to feel comfortable that your local operations are being overseen by experienced business executives like yourselves.

If you choose us as your Medsafe Sponsor we stay close to you and work with you to make sure you avoid regulatory issues with your product(s), packaging or marketing.   

We can also help you in many other ways to structure and grow your business effectively.

Next steps?

We want to talk to you about your product(s), your company, your international sales elsewhere in the world and your aspirations for the NZ market.  We ask you what contacts you already have in our markets – a distributor, for example, or a regulatory consultant?  Do you need more information about the local markets or are you ready to get going?  

And we tell you about us – who we are, our experience and our services.

So what does it cost you to use RSA as your Medsafe Sponsor?  Our pricing is competitive.  We keep it simple, and fair.  We provide an informal cost estimate after we know which services you need, following by a formal proposal if you are happy to proceed.

We treat all information received as confidential but we will sign a NDA at any time.  To formalise arrangements we enter a contract with you setting out all the services contracted, pricing and general terms and conditions.