Exportation and Regulation of Medical Devices
If you need to bring your products to market in compliance with the most demanding regulations, we are here to help. With our experience in regulations in the United States, Europe, the United Kingdom, Canada, Dubai and more, we offer you the necessary support so that your devices meet the highest standards of safety and efficiency.
Simplify the approval process and ensure the success of your medical devices.
Let us guide you through the complex world of healthcare regulation!
What are Medical Devices?
Medical devices are instruments, apparatus, software, materials or other items used in the diagnosis, prevention, monitoring, treatment or relief of diseases or medical conditions. These devices do not achieve their purpose through pharmacological, immunological or metabolic means, as drugs do, but through physical or electromechanical mechanisms.
General Principles in Medical Device Regulations
Risk Assessment and Classification
All regulatory systems classify medical devices according to the potential risk they may pose to the user.
Studies
Clinicians
For more complex or high-risk devices, safety and efficacy must be demonstrated through clinical studies.
Post-Marketing Surveillance Systems
Once on the market, devices must be monitored to detect and resolve any security issues.
Evaluation of
Accordance
Manufacturers must demonstrate compliance with applicable regulatory standards through technical documentation.
Medical Device Regulations
in Different Markets
USA
FDA (Food and Drug Administration)
The FDA regulates medical devices in the US through the Center for Devices and Radiological Health (CDRH).
Classification: Devices divided into three classes according to risk (Class I, II and III).
Registration and pre-approval: Manufacturers must register their devices and obtain approval. Class I devices typically require only registration notifications, while Class III devices must go through more rigorous processes such as Premarket Approval (PMA).
510(k): Process that allows manufacturers to demonstrate that their device is "substantially equivalent" to an already approved device, avoiding a full evaluation for Class II devices.
Clinical research : Class III devices require clinical trials before approval.
European Union
MDR Regulation (Medical Device Regulation)
In Europe, medical devices are regulated by MDR 2017/745, which replaced the Medical Devices Directive (MDD).
Classification: It is classified into classes I, IIa, IIb and III, based on the level of risk.
CE Marking: Devices must obtain the CE marking to demonstrate that they comply with the MDR requirements.
Notified Bodies: Authorized bodies (Notified Bodies) assess the conformity of devices, especially those with higher risks (IIa, IIb and III).
Clinical research: High-risk devices require clinical studies.
Post-marketing surveillance : A post-marketing surveillance system is established to ensure continued safety.
United Kingdom
MHRA (Medicines and Healthcare products Regulatory Agency)
Following Brexit, the UK continues to regulate medical devices through the MHRA, although it has decoupled itself from the EU's MDR regulation.
Classification: Devices are classified similarly to the European Union (Class I, IIa, IIb and III).
UKCA Mark: Since January 2021, devices in the UK must bear the UKCA Mark (instead of the CE mark) to demonstrate their compliance with UK regulations. However, the CE mark remains temporarily valid until the end of 2024.
Notified Bodies: In the UK, conformity assessment bodies must be registered with the MHRA and are responsible for the assessment of higher risk devices.
Clinical research: High-risk devices require clinical trials before being marketed.
Canada
Health Canada
Health Canada regulates medical devices through the Medical Devices Bureau. The classification of medical devices in Canada is similar to that in other markets, in four classes.
Classification: They are divided into four classes according to risk (Class I, II, III and IV).
Registration: Class II, III and IV devices require a Medical Device License for marketing. Class I devices must be registered, but do not require a license.
Clinical Studies : For Class III and IV devices, clinical evidence is required to support the safety and effectiveness of the device prior to approval.
Seal of Conformity (MDSAP): Canada participates in the Medical Device Single Audit Program (MDSAP), which allows a single audit to meet regulatory requirements in multiple markets, including the US, EU, and Japan.
Post-marketing surveillance: Manufacturers must comply with post-marketing surveillance regulations and report adverse incidents to Health Canada.
Dubai (United Arab Emirates)
Dubai Health Authority (DHA)
In Dubai, the Dubai Health Authority (DHA) regulates the marketing and distribution of medical devices. In addition, the Ministry of Health and Prevention (MOHAP) oversees health standards throughout the UAE.
Classification: Similar to other international systems, devices are classified according to risk (Class I, II, III).
Registration: Medical devices must be registered and approved by MOHAP to be marketed. For low-risk devices, the approval process is simpler, while for higher-risk devices, clinical evidence is required.
Importation: International companies wishing to market their products in Dubai must work with local distributors who are registered and licensed by the DHA.
International Standards: Dubai adopts international standards such as those of the FDA and EU, so the approval process can often be easier if the device already has approvals from these markets.
Con más de 10 años de experiencia en evaluaciones de seguridad cosmética, food suplements, homecare products y medical devices, BELAB SERVCES ofrece una solución integral y confiable para verificar y registrar sus productos de manera efectiva. Nuestra solución, basada en un profundo conocimiento de la legislación, cuenta con un equipo de consultores científicos y herramientas informáticas avanzadas, convirtiéndose en la vía más rápida y confiable para acceder al mercado europeo.
