Regulatory Consulting
Regulatory Consulting: Registrations in Europe, the UK, the USA, Canada, and Key International Markets
For manufacturers of Medical Devices and In Vitro Diagnostic Devices who need support to export their products worldwide, overcoming the complex maze of regulations and laws that represent the new real market entry barriers.
Only an in-depth understanding of each country’s regulatory requirements can lead to an integrated and optimized pathway that effectively supports a company’s commercial strategy — something that can be achieved only by organizations equipped with true Regulatory Affairs specialists.
Maytal offers Medical Device (MD) and In Vitro Diagnostic (IVD) manufacturers a comprehensive Regulatory Affairs outsourcing service, combining specialized technical and regulatory expertise. This enables companies, even small and medium-sized ones, to build a strategic route to achieve rapid product commercialization in the world’s most important markets.
Trust the Maytal experience
Tailor-made solution for every market
Registration in the EU
REGISTER IN EUROPE WITH CONFIDENCE AND PRECISION: Preparation, review, and maintenance of technical documentation (MDR or IVDR), support in managing relationships with the Notified Body, and guidance throughout the CE certification process.
Registration in the USA
We guide manufacturers through the U.S. market registration process, preparing applications (e.g., 510(k)), supporting them in interactions with the FDA for Device Listing and Establishment Registration, and assisting during the post-market phase (e.g., complaint handling, authority reporting, etc.). We also provide U.S. Agent services.
Registration in the UK
We handle product registration on the MHRA portal as a UK Responsible Person (UKRP) and take care of the preparation and review of technical documentation according to UK MDR requirements, to support the achievement of the UKCA marking
Registration in Canada
We support manufacturers throughout the Canadian market registration process, preparing product applications (MDAL), assisting in communications with Health Canada, and managing the establishment license (MDEL) process — all the way through to the post-market phase.
Access to International Markets
We support manufacturers with an integrated approach, combining regulatory strategy, compliance expertise, and market insight to ensure efficient and secure access to international markets (Australia, Brazil, Japan, India, Saudi Arabia, UAE, etc.), offering a comprehensive and tailored service.