Regulatory Funding Opportunity for Health Tech SMEs

1/3/2022

Yes!

You read it right!

Innovate UK, in association with CPI and ABHI, have developed the 'Health Technology Regulatory and Innovation Program', which aims to support Small and Medium-sized Businesses (SMEs) to navigate the complex and ever-changing HealthTech regulatory landscape.

Many companies utilize services from service providers like us and Med-Di-Dia, who provide a wide range of regulatory support and become regulatory risk partners. Our services are bespoke and tailored as per the need of the client. As we all know, without a regulatory strategy, innovation will not make it to the market and can face serious complications to the extent of criminal offence and product recalls. It is often seen that innovators fear the regulatory requirements and make mistakes which lead to serious consequences. This fear is either because of a lack of awareness or lack of funding.

Here is a golden opportunity for innovators to apply for funds up to £30,000 specifically to navigate the ever-changing regulatory landscape. Why is this a golden opportunity?

Well, through this funding, innovators need to worry less about the cost of regulatory affairs involved in making their innovation comply with market regulatory requirements. Since this funding enables stronger compliance with regulatory requirements, innovators have scope to remap their budgets and focus on additional expenses that might allow the creation of breakthrough technology. The innovators benefit from product sales and market access with complete regulatory conformity, and the end-users get the advantage of using and experiencing a completely safe health tech solution.

Let's understand more about this funding:

What exactly is this funding?

The aim of this program is to support small and medium-sized companies (SMEs) that are currently producing or are developing products in the medical technology (MedTech), health technology (HealthTech), diagnostics (including in-vitro diagnostics) and Software as a Medical Device (SaMD) markets to access regulatory-related advice and support. This is currently very pertinent as the UK, and the EU, have seen changes to medical device [MDR] and in vitro diagnostic device regulations [IVDR] which will affect the UK industry. This project seeks to offer support to the UK health technology industry to mitigate these changes.

Companies can apply for grant funding for regulatory support up to £30,000 per company.

Regulatory support may include but is not limited to activities such as:

Global registrations
Mock audits
Quality
Clinical guidance pertaining to regulatory affairs
Technical guidance relating to standards
Guidance on MDR, IVDR, FDA
Advice on reimbursement models
Guidance on Technical File development
Contributions towards remedial action (for example electrical safety testing, biocompatibility testing etc)
Notified Body costs.

Innovators also have an option to contact the project support team and ask for other areas of regulatory affairs that are eligible for this round. [Click here to send email] – or health.techprogramme@uk-cpi.com

How can I apply for this fund?

A single round of grant funding will be made available, which will start on 14th February 2022 and close on the 31st May (12:00 midday GMT) 2022. Applications will be funded on a first-come, first-served basis for companies that meet both the qualifying criteria and a minimum score threshold in their application. Read more about How to Apply.

Where should the service provider be located?

Funding must be used with a regulatory support provider based in the UK. If there is an intention to use a provider outside of the UK, a justification for this will be required.

Don't worry!

Global Regulatory Service Ltd (GRS) and Med-Di-Dia Ltd – both can be your regulatory risk partners and service providers under this fund! While we have been in this business for 17 years, the project support team will still conduct their round of due diligence. Hence, your trust in us is re-assured!

What next?

Once you and the provider of regulatory support [GRS/Med-Di-Dia] have entered into an engagement, the agreed support has been provided to you, and a valid invoice has been provided to the Project Support Team, you will then be paid the eligible costs of that support - up to £30,000 [VAT guidance].

Anything I need to be aware of?

Payment is conditional on you [innovator/fund applicant] agreeing to complete a survey(s) and/or be interviewed by the Project Support Team about the support you are receiving and other challenges facing your business/industry.

This funding is being awarded under Article 3.2(3) of the Trade and Cooperation Agreement between the European Union and the United Kingdom. There is a subsidy threshold of 325,000 Special Drawing Rights (approx. £335,000) per individual company, business, or group over any period of three fiscal years, including the current year.

We suggest you look at the section entitled "Special Drawing Rights (SDRs) and EU de minimis awards". As you cannot receive more than 325,000 Special Drawing Rights over a period of three fiscal years, including the current year, you must declare if you receive funding through this grant programme, that it does not cause you to exceed your Special Drawing Rights limit.

How can GRS/Med-Di-Dia Help?

Our experts will be your regulatory risk partners and can provide you with complete support on:

Global registrations [Let’s go global!]
Mock audits
Quality
Clinical guidance pertaining to regulatory affairs
Technical guidance relating to standards
Guidance on MDR, IVDR, USFDA
Advice on reimbursement models
Guidance on Technical File development
Contributions towards remedial action (for example electrical safety testing, biocompatibility testing etc)
Notified Body costs.
Acting as your EU Authorised Representative [EU AR]
Acting as your Person Responsible for Regulatory Compliance [PRRC]

Want to apply for this fund?

Click Here

Want to know more?

Click Here

Wanting a regulatory risk partner and service provider?

Send us an email at grs@globalregulatoryservices.com

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