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Hassle-Free UK MHRA Compliant Importing

Medical Device Importing Services UK

Since Brexit, the UK requires non-UK manufacturers exporting medical devices into the UK to meet distinct regulatory requirements under the UK Medicines and Medical Devices Act (MMDA). GrowthImports acts as your trusted, independent importer to ensure full MHRA compliance. With our support, you can streamline the medical device registration in the UK, secure market access, minimize dependency on multiple distributors, and prevent channel conflicts.

Medical Device Importing services United Kingdom

Guarantee Compliance, Stay Efficient

Easy Medical Device Market Access in Great Britain

By partnering with a single MHRA-compliant UK medical device importer, you reduce risks associated with regulatory non-compliance and avoid the operational challenges of managing multiple distribution channels. Our comprehensive service ensures that your medical device registration in the UK meets all required standards, giving you peace of mind as you access the UK market.

GrowthImports has decades of expertise in regulatory compliance and import services. We offer cost-effective, reliable solutions that allow you to maintain control over your products and streamline medical device importing into the UK. Our UK MHRA importer services are also applicable for UKCA-marked devices and legacy devices, adhering to the latest MHRA requirements to keep your business compliant and efficient.

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MHRA Importer Regulations UK

The UK Medicines and Medical Devices Act (MMDA) mandates non-UK manufacturers to assign a UK-based importer who can oversee compliance with MHRA regulations. This UK importer is jointly liable for all products placed on the market and ensures that they meet all UK medical device regulatory requirements.

The MHRA (Medicines and Healthcare products Regulatory Agency) is continuously reviewing and updating regulations to improve product safety and market accountability. Recent consultations indicate a stronger focus on reporting and traceability for imported medical devices. GrowthImports stays up-to-date with these developments to help you meet current and upcoming UK medical device registration requirements.

 

Independent Medical Device Importer for all European Markets
How we make MDR/IVR possible

Streamlined Onboarding for Medical Device Importing into the UK

At GrowthImports, we simplify the onboarding process for importing medical devices into the UK by closely working with your team to align on regulatory requirements. After determining the scope of your import activities, we create a structured plan and formalize this in our service agreement. Based on the number of expected imports and the Unique Device Identifier (UDI-DI), we tailor a compensation structure to suit your specific needs.

Our onboarding includes a comprehensive submission checklist, which can be managed through our secure cloud portal, ensuring efficient and protected information exchange. Once all documents are verified, you will receive an importer statement, and the import process can commence. With our approach, you can ship directly to customers without needing physical importation to our location, saving time and logistics costs.

MDR/IVDR Importing Services for UK

Our staged growth development framework contains deliverables and an actionable planning aimed to evaluate, optimize and exceed global growth objectives of our Clients.

 

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Maintain Efficiency, Eliminate Compliance Risk and Minimize cost

Navigating the complexities of importing medical devices into the UK can be challenging, especially when managing multiple distributors and compliance partners. GrowthImports provides a streamlined solution, eliminating the need to coordinate with numerous entities and reducing the risk of compliance issues. Our services simplify market access, minimize compliance risks, and lower administrative burdens, allowing you to focus on growing your business without the complications associated with channel conflicts.

We operate as an MHRA-compliant importer and are certified to ISO 13485 standards, ensuring that every step aligns with UK regulatory requirements. This approach guarantees that your products meet all UK medical device registration standards while maintaining smooth alignment with your team and operational processes. GrowthImports offers a single, reliable point of contact for all your compliance needs, freeing you from managing multiple importers or distributors.

Let's Explore Your International Growth Opportunities!

Our expert consultants are ready to assist with all aspects of medical device importing into the UK. Whether you need help with MHRA compliance, medical device registration, or market strategy, we’re here to make your journey into the UK market as seamless as possible.

Book a meeting with us today and let’s secure your success in the UK’s medical device market!

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