CMC works with manufacturers in over 70 nations, focusing on requirements related to MDR and IVDR. Credit: Panchenko Vladimir / Shutterstock.com.
Registrar Corp has acquired CMC Medical Devices, a Spain-based company specialising in clinical, regulatory, and compliance services, for an undisclosed sum.
CMC works with manufacturers in more than 70 nations, focusing on requirements related to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), authorised representation, and strategies for navigating regulatory frameworks.
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Backed by Paine Schwartz Partners, the deal will see Registrar Corp aim to integrate its network with CMC’s technical and clinical offerings, providing a combined service to help medical device and IVD companies to bring products to market.
Registrar Corp will now provide services as an authorised representative or sponsor in Australia, China, the US, the UK, the European Union (EU) and Switzerland, assisting manufacturers with regulatory compliance across these regions.
The acquisition also enables Registrar Corp to manage Free Sale Certificates from key jurisdictions, streamlining export documentation processes and supporting quick approvals for the product.
Furthermore, CMC’s clinical network allows Registrar Corp to deliver additional services such as developing plans for data gathering, reporting on post-market clinical follow-up (PMCF), and providing detailed guidance on MDR and IVDR regulations.
Registrar Corp CEO Raj Shah said: “We’re proud to welcome CMC Medical Devices to the Registrar Corp family.
“Together, we offer medical device manufacturers a single partner to navigate complex regulations and access the US, EU, and other key global markets—so they can focus on innovation rather than compliance.”
According to Registrar Corp, this development is intended to ease global expansion for manufacturers by minimising associated expenses, challenges, and timelines.
With a suite of regulatory, clinical, and compliance solutions now available through a single provider, medical device and IVD firms are positioned to benefit throughout all phases of product compliance and commercialisation.
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