Global Regulatory Requirements for Medical Devices

Intertek provides streamlined and efficient global market entry for your latest 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.

CB Scheme, Medical CB Scheme, CB Scheme for Medical Devices

The IECEE CB Scheme and Medical Devices

Intertek provides CB Scheme Certification issuing more CB certificates than any other National Certification body giving you access to global Medical Device markets

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Seamless US Market Entry for Medical Devices with Intertek

As a recognized NRTL, Intertek conducts testing and certification to ensure compliance with OSHA’s workplace safety standards, addressing critical requirements for medical devices such as hospital equipment, diagnostic tools, powered medical systems and more.

Medical ECG patient device for monitoring vital signs including heart rate and more

FDA ASCA Program

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

China NMPA Requirements for Medical Devices

Intertek can help you unlock market opportunities to export Medical Devices in the fast-growing China healthcare market with guidance on China NMPA Requirements.

Hospital room with two medical beds and ventilator systems, against a blue wall

Comply With Japan’s PMD Act Requirements for Medical Devices

With our global presence and local expertise, we ensure that your products align with the unique requirements of the Japanese market under the Pharmaceutical and Medical Device Act (PMD Act)

Medical room filled with Hemodialysis equipment and chairs

Meet Brazil’s Medical Device Regulations with Confidence

Intertek offers comprehensive solutions to address Brazil’s INMETRO Ordinance 384/2020 detailed requirements, including testing, certification, and audit processes tailored to medical devices.

Medical professional assisting mature man with grey beard on the table of a CT scanner

SATELLITE™ Client Test Program For Medical Devices

Intertek’s SATELLITE™ Client Test Program revolutionizes compliance for medical device manufacturers, giving you the ability to perform testing in your own facilities while maintaining adherence to critical standards like IEC 60601-1, 60601-1-2, and IEC 61010