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Mutual recognition of medical devices: strategically planning your pathway to market

Published by Isabella Greenock, Medical Device Paralegal on

Mutual recognition agreements (MRAs) are arrangements between two or more countries to recognise each other's regulatory processes and/or procedures. MRA’s are not uncommon in the medical devices regulatory sector - indeed, we recently wrote about the Therapeutic Goods Administration’s announcement that it will start accepting approvals from the Singapore Health Sciences Authority in relation to certain classes of medical devices and IVDs on the market in Australia.[1]

In this post we discuss several key MRAs relevant to medical devices and how you can take advantage of these arrangements when planning your go to market strategy. 

Australia-European Union

One of the most established medical device MRAs is between Australia and the European Union. Under this agreement, EU-based companies can have their devices tested and approved against the Australian regulations by an EU notified body. For manufacturers, the EU-AU MRA presents a significant advantage as it allows the same Notified Body to be used for both their EU and Australian conformity assessment. Since the medical device regulations in Australia are substantively similar to those in the EU, relying on this pathway for devices already certified against the EU regulations will involve relatively minor costs and effort for EU-based companies.

The EU-AU MRA also allows Australian companies to rely on Australian organisations when carrying out EU conformity assessments. However, as the MRA was negotiated prior to the implementation of the EU’s new medical device regulations, it only covers assessments under the old (now repealed) medical device directives. The TGA is currently in the process of negotiating an updated agreement with the European Commission to allow Australian organisations to issue conformity assessment certificates against the new EU regulations. 

A similar MRA has also been established between Australia and the United Kingdom following the UK’s withdrawal from the EU.

United States-United Kingdom/European Union

The US has MRAs in place with both the UK and the EU. While these agreements do not go as far as the EU-Australia MRA in recognising conformity assessment procedures for medical devices,[2] they do cover a number of areas that may be relevant to device manufacturers. In particular, the US-EU/UK MRAs cover:

  • Electromagnetic compatibility (EMC)
  • Telecommunication equipment

These MRAs may therefore be of interest to manufacturers of devices which are electrically powered or which have functions that are implemented using electrical circuitry (meaning they have to comply with EMC regulations), as well as devices that may be connected to public telecommunications networks (requiring compliance with telecommunications regulations). The MRAs allow such devices to be tested against the relevant US regulations in the EU/UK by an EU/UK conformity assessment body and vice versa. 

Israel-GHTF Countries

The final arrangement we discuss in this post is not technically a mutual recognition agreement, but may nevertheless be of interest to manufacturers when developing their go to market strategies. 

Israel’s medical device registration system is based on prior approval from one of the five founding members of the Global Harmonisation Task Force (GHTF) - namely, Australia, Canada, the European Union, Japan, or the United States. Under Israel’s medical device regulatory framework,[3] medical devices which have been authorised for marketing by one of these five GHTF members may also be registered in Israel on the basis of the foreign authorisation. To take advantage of this arrangement, manufacturers must appoint an authorised representative in Israel to interact with the Medical Device Division of the Israeli Ministry of Health (AMAR) on their behalf.

It is important to note that this is a one way (rather than a mutual) system of recognition, meaning that authorisations granted under Israel’s medical device framework are not afforded special treatment in any GHFT countries. However, for manufacturers of devices already approved in one of the recognised GHFT countries who are also looking to enter the Israeli market, this is a useful pathway for expediting the approval process and expanding their market territory. And for manufacturers who have not yet looked at Israel as a potential target country – as one of the largest medical device markets in the Middle East and with approximately 65% of the market being import driven – this may be a jurisdiction worth considering!

Planning your go to market strategy

When leveraged effectively, mutual recognition agreements can help manufacturers boost the global reach of their products. Whether through the full recognition of medical device conformity assessments (as with the Australia-EU/UK MRAs), or the recognition of elements of the approval process that may be relevant for certain types of devices (as with the US-EU/UK MRAs), MRAs provide a useful pathway for those looking to expand their target countries without having to start the approval process for scratch. We therefore recommend that manufacturers at least consider the possibility of taking advantage of a medical device MRA when planning their longer term market strategies. 

If you are interested in marketing your medical device in any of the countries mentioned in this post and would like to find out more about the approval process, please register your interest in our Regtik platform. Regtik provides a guided assessment that directs your device through the regulatory maze, followed by a fully reasoned report outlining key information (including device classification and pathways to market). It is currently able to assess devices against the US, EU, UK and Australian regulations, highlighting key features of the requirements applicable to your device in each country which may help when deciding which markets to prioritise. If you are interested in learning more about Regtik or would like to request a demo, please contact any member of our team or register your interest below.

 


[1] Australian TGA to recognise approvals from Singapore’s HSA

[2] The US-EU MRA was originally intended to cover medical device conformity assessment, however this aspect of the agreement is currently non-operational

[3] Medical Equipment Law 2012, section 6(b)