Learn about what Global Medical Device Regulations regulatory stands for:
This article has been updated May 29, 2025. If you are strong exporter of medical devices, you should know about global medical device regulations.
Canada
Medical device regulation in Canada is governed by the Food and Drugs Act and the Medical Devices Regulations, overseen by Health Canada. The regulatory system is recognized as one of the most stringent globally, aiming to ensure the safety, effectiveness, and quality of medical devices distributed in the country.
- Devices are classified into four risk-based classes (Class I–IV).
- Class II, III, and IV devices require a Medical Device License (MDL); Class I requires a Medical Device Establishment License (MDEL).
- Higher-risk devices (Class III & IV) need robust clinical evidence for approval.
- Health Canada monitors devices post-approval through scientific review, inspections, and enforcement.
Europe (European Union)
The European Union regulates medical devices under Regulation (EU) 2017/745 (Medical Device Regulation, MDR) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Device Regulation, IVDR), which replaced older directives in 2021 and 2022, respectively.
- Stricter requirements for clinical evaluation, post-market surveillance, and device traceability.
- Devices classified by risk; notified bodies assess higher-risk devices.
- Transition periods for older devices, but new devices must comply with updated regulations.
Korea (South Korea)
In South Korea, the Ministry of Food and Drug Safety (MFDS) is responsible for regulating medical and in vitro diagnostic devices. All devices must be registered with the MFDS, and the regulatory pathway depends on the device’s risk classification.
- Devices without a predicate require clinical data review.
- Manufacturers must appoint a Korean License Holder (KLH).
- Korean Good Manufacturing Practices (K-GMP) certification required for most devices.
- Approved devices receive marketing authorization and are listed on the MFDS website.
Kuwait
Kuwait’s Ministry of Health (MOH) has recently implemented new ministerial decrees to regulate the registration and distribution of medical devices, aligning with international standards.
- Devices classified into four categories based on usage and impact.
- Regulations align with international standards and streamline registration.
- Aimed at improving efficiency and market access for both local and foreign companies.
Malaysia
Malaysia’s Medical Device Authority (MDA), under the Ministry of Health, regulates medical devices through the Medical Device Act 2012.
- Devices classified into four risk-based classes (A–D).
- All establishments (manufacturers, importers, distributors) must be licensed.
- Devices must be registered with the MDA before marketing.
- Framework ensures public health and safety while supporting industry growth.
Qatar
Medical device regulation in Qatar is evolving, with current requirements stipulating that devices must first be authorized by one of the founding members of the Global Harmonization Task Force (GHTF) to gain market access.
- Local representation required for registration.
- Regulatory framework is evolving, with increasing focus on market controls and post-market surveillance.
- Expected to further align with global best practices.
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) regulates all medical and in vitro diagnostic devices in the Kingdom.
- All medical and in vitro diagnostic devices require pre-market approval.
- Devices classified according to SFDA rules.
- An Authorized Representative (AR) in Saudi Arabia is required.
- Registration involves submission of technical documentation and fees; approval grants a Medical Device Marketing Authorization (MDMA) certificate.
Singapore
Singapore’s Health Sciences Authority (HSA) regulates medical devices under the Health Products Act and its associated regulations
- Dealer’s license required for manufacturing, importing, or supplying devices.
- Most devices require registration; Class A (lowest risk) may be exempt under certain conditions.
- HSA oversees adverse event reporting, safety actions, and clinical trials.
UAE (United Arab Emirates)
The United Arab Emirates regulates medical devices through the Ministry of Health and Prevention (MOHAP).
- Devices must comply with UAE standards and require local representation for registration.
- Regulatory framework includes detailed classification and approval processes.
- MOHAP oversees approval, monitoring, and post-market surveillance.
USA (United States)
In the United States, the Food and Drug Administration (FDA) regulates medical devices through a risk-based classification system.
- Devices classified into three risk-based classes: Class I (lowest), II, and III (highest).
- Regulatory requirements increase with risk: from general controls to premarket approval (PMA) for Class III.
- Manufacturers must register establishments, list devices, and comply with quality system regulations (QS), harmonizing with ISO 13485:2016.
- FDA mandates labeling and medical device reporting (MDR) for adverse events.
