Global Regulatory Requirements for Medical Devices

Intertek is your trusted partner in navigating the complex world of Global Regulatory Requirements for medical devices. With expertise in standards and certifications worldwide, we provide the tools and guidance you need to achieve compliance and accelerate market entry anywhere in the world.

Our comprehensive services cover critical programs such as the CB scheme, ensuring seamless international certification for safety and performance standards. For manufacturers targeting North America, our ETL certification is recognized as proof of compliance to US and Canadian standards. As an FDA-approved testing laboratory, Intertek participates in the FDA ASCA program, expediting premarket submissions with recognized data for medical device compliance.

We also support regulatory pathways for key global regions, including China, Japan, and Brazil, helping you overcome regional complexities and gain access to these important markets. Intertek’s Satellite program further empowers manufacturers by enabling in-house testing aligned with international standards, reducing time to market while ensuring compliance with global expectations.

From streamlined certification processes to localized regulatory expertise, Intertek provides a one-stop solution for ensuring your medical devices meet global requirements. Our experts will unlock new opportunities and bring your innovations to patients worldwide with confidence and efficiency.

The IECEE CB Scheme and Medical Devices

Fast, efficient CB Scheme Certification to help medical device manufacturers gain access to more markets around the world.

Seamless US Market Entry for Medical Devices with Intertek

Industry-leading expertise and accreditations to help you with U.S. approvals for medical devices.

FDA ASCA Program

The FDA's ASCA Program is aimed at ensuring quality and accuracy in medical device pre-market submissions. The goal is to make the process more efficient and add confidence in the levels of safety, performance, and quality assurance.

China NMPA Requirements for Medical Devices

Unlock market opportunities to export Medical Devices in the fast-growing China healthcare market with guidance on China NMPA Requirements.

Comply With Japan’s PMD Act Requirements for Medical Devices

Japan’s Pharmaceutical and Medical Device Act (PMD Act) sets stringent regulatory requirements for medical devices entering the Japanese market.

Meet Brazil’s Medical Device Regulations with Confidence

Expert guidance to navigate Brazil’s medical device regulations.

CE Marking for Medical Devices

Comprehensive Testing and Certification services guiding you through every step of the CE Marking process for Medical Devices.

SATELLITE™ Client Test Program For Medical Devices

Product compliance testing in your own labs and on your own schedule while obtaining our market-leading Certifications.

Global Market Access

The simplest way to find compliance data for countries around the world and to build a customized Access roadmap.