Your Gateway to Global Markets

Navigating the regulatory landscape for medical devices can be complex, especially when targeting multiple regions. In an increasingly interconnected world, navigating the complex landscape of medical device regulations is crucial for your product’s success.

Our expert team specializes in global medical device registration, providing comprehensive support for compliance in major markets including but not limited to the USA, EU, UK, Australia, Canada, Brazil, and Japan. Whether you’re seeking to enter a single market or multiple regions, we simplify the process, enabling you to focus on your innovation.

Our comprehensive services help you implement and maintain QMS compliant with ISO 13485 and MDSAP standards, facilitating global market access.

Register medical devices to place on the market, Global Registration

Our Comprehensive Services

Global Registration Consulting for Medical Devices and IVDs

Entering the U.S. market requires a solid understanding of FDA regulations. We assist with:

  • 510(k) Submissions: For devices that are substantially equivalent to existing products.
  • Premarket Approval (PMA): For high-risk devices that require extensive clinical data.
  • Quality System Regulation (QSR): Ensuring adherence to FDA manufacturing standards.
  • De Novo Classification: For devices that do not fit into existing categories, de novo classification may be necessary.

The EU Medical Device Regulation (MDR) has introduced stringent requirements. Our services include:

  • CE Marking: Guidance through the certification process, ensuring compliance with EU standards.
  • Technical Documentation Preparation: Assisting with clinical evaluations and necessary technical files.

Post-Brexit, the UK has established its own regulatory framework:

  • UKCA Marking:We navigate the requirements for you to obtain the UK Conformity Assessed mark.

The Therapeutic Goods Administration (TGA) governs medical device regulation in Australia:

  • TGA Approval: We facilitate the process for listing your devices on the Australian Register of Therapeutic Goods (ARTG).

Health Canada oversees the regulation of medical devices:

  • Medical Device License (MDL): Our experts assist you in the application process, ensuring compliance with Canadian regulations.

The Brazilian Health Regulatory Agency (ANVISA) has specific requirements:

  • ANVISA Registration: We provide guidance on the registration process to gain market access in Brazil.

The Pharmaceuticals and Medical Devices Agency (PMDA) regulates medical devices in Japan:

  • Shonin Approval: We guide you through the necessary steps to secure approval for your devices.

The Medical Device Single Audit Program (MDSAP) offers a streamlined approach to meeting regulatory requirements across multiple countries. By participating in MDSAP, your organization can satisfy the audit requirements of:

  • FDA (USA)
  • Health Canada
  • ANVISA (Brazil)
  • TGA (Australia)
  • PMDA (Japan)

Our team is here to help you:

  • Regulatory Submissions: We assist with the preparation and submission of regulatory documentation to participating regulatory authorities.
  • Prepare for MDSAP Audits: Providing tailored support and training to ensure your compliance with the MDSAP framework.
  • Audit Representation: Our experts can accompany you to your MDSAP audit to provide support and address any questions from the auditors.
  • Corrective Action Plans: If any non-conformities are identified during the audit, we help you develop effective corrective action plans to address the issues.
  • Develop Robust Quality Management Systems: Enhancing your operational processes to meet international standards.
  • Post-Audit Support: We provide ongoing support to ensure that your quality management system remains compliant with MDSAP requirements.

Why Choose Us?

medical device registration, global medical device compliance, regulatory approvals, medical device market access, medical device certification, international medical device standards, Sushvin medical registration services
  • Expertise Across Markets: Our regulatory affairs specialists have extensive knowledge of the requirements in each target market.
  • Customized Strategies: We understand that each medical device and company has unique needs. Our services are tailored to fit your specific goals.
  • Full-Service Support: From initial strategy development to post-market surveillance, we’re with you every step of the way.
  • Proven Success: Our track record includes successful registrations across various global markets, giving you confidence in our capabilities.
Get In Touch

Start Your Global Journey Today!

Don’t let regulatory hurdles impede your progress. Get in touch with us today to ensure your medical device achieves compliance and reaches the global market effectively. Contact us today to discuss your registration needs and take the first step toward successful market entry!

Reach out today to discover how Sushvin's team can assist you.

Discover Our Range of Services

Sushvin provides a wide range of services designed to cater to the diverse needs of our clients. Our extensive service offerings include:

Subscribe To Our Newsletter

For Latest Updates, Subscribe to our monthly newsletter today!