Global Regulatory Requirements - Medical Equipment

Global regulatory requirements for medical devices are critical because they ensure the safety, efficacy, and quality of medical devices, thereby protecting public health and safety. They establish stringent safety and performance standards, minimizing risks to patients while ensuring devices deliver the intended clinical benefits. Harmonized regulations across markets, such as those promoted by the IMDRF, reduce duplicative efforts, streamline global market access, and lower costs for manufacturers. Compliance with these requirements facilitates broader distribution, builds trust among stakeholders, and encourages innovation within a clear and ethical framework. Additionally, regulatory oversight includes post-market surveillance to monitor device performance, report adverse events, and implement recalls if needed, ensuring ongoing safety and improvement. By fostering consistent standards globally, these regulations support public health, enhance patient outcomes, and promote equitable access to high-quality medical devices.

To bring your medical device to North American, European and global markets with speed and efficiency, you need a testing and certification partner who knows your business. Count on Intertek for compliance testing and certification to harmonized global standards and requirements, all from a single source.

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

CE Marking for Medical Devices

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

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.

In Vitro Diagnostic Directive (IVDD) 98/79/EC

All In vitro diagnostic medical devices are subject to European Directive IVDD 98/79/EC. Intertek can help navigate and meet the essential requirements of IVDD.

MDR Certification | EU Medical Device Regulation 2017/745

The aim of the new Medical Device Regulation is to address some inherent weaknesses in the old directives as well as the swift evolution of science and technology in the field of medical devices.

SATELLITE™ Client Test Program

Conduct product testing in your own labs and on your own schedule while obtaining our market-leading Certifications with our SATELLITE™ Client Test Program

Global Market Access

Unlock your product’s true potential with Global Market Access from Intertek

Medical Device Market Requirements Certification Guides

Download: China NMPA Requirements For Self-Testing

In order to import medical devices into China, manufacturers must obtain approval from the National Medical Products Administration (NMPA). Download our overview of the new self-testing requirements.

Medical Device Market Requirements for Brazil

Download our free Market Guidance Document for medical device regulatory requirements in Brazil. This guide outlines the compliance assessment steps in accordance with Ordinance 384/2020, the standard for the safety and performance of electronic medical equipment.

Pharmaceutical and Medical Device Act (PMD Act) and Market Requirements for Japan

It is necessary to comply with the Pharmaceutical and Medical Device Act (PMD Act) when importing and selling medical devices from overseas into Japan. Download our free market access guide to ensure your products comply.