Medical Device Registration & Approvals:
Navigating medical devices and equipment approvals can be challenging. At 5M Global, we specialize in product registration and regulatory approval for medical devices (Class I, II, III) across global markets. Our expertise ensures compliance with standards like FDA 510(k), EU MDR (CE Marking), MHRA (UK), TGA (Australia), and more.
Our Services:
- Regulatory Consultation: Comprehensive guidance on global requirements and strategy.
- Certification Support: Assistance in obtaining necessary approval certifications.
- Market Access: Navigating entry into new markets, meeting local and global regulations.
Key Regions: Middle East, Africa, and Asia.
Why Choose Us?
- Expertise: In-depth knowledge of global regulations.
- Efficiency: Streamlined approval processes, reducing time to market.
- Global Reach: Support in over 120 countries.
- Customer Focus: Prioritizing your success.
Global Regulatory Approval for Medical Device Registration
Medical device regulations vary by country, making it essential for manufacturers to understand and navigate these differences to enter the global markets. Efforts to harmonize regulations and promote international collaboration aim to simplify this process and improve patient safety on a global scale.
Each country has its own unique set of regulations and requirements based on, such as product classifications, risk levels, product claims, and intended use. Medical device registration globally includes the FDA (United States) 21 CFR 820, ISO 13485 standards, European Union (EU) Medical Device regulations 745/2017( CE Mark), MHRA (UK), TGA (Australia), and more. They also need to be prepared to renew their registration annually and comply with the Regulatory Authorities’ requirements.
Registering medical devices in the international markets in each country is necessitates a tailored approach, involving close collaboration with the relevant Health Authorities for approval.
The typical process for medical device registration involves the following steps:
- Assessing whether a specific device / medical equipment’s are meets the criteria for classification as a medical device.
- Categorizing devices based on the associated risks and intended use.
- Identifying the relevant international and regional standards, technical documents, and data prerequisites specified by the respective Health authorities.
- Generating the necessary data as mandated by the Health Authority.
- Compiling a technical file in accordance with the specific requirements of each country.
- Submitting the application and addressing any queries or concerns until approval is obtained.
- Managing the device’s lifecycle post-approval.
Post Approval Device Life Cycle Management
- Post-approval change management – modifications to existing Medical Device approvals such as the addition of new variants, accessories, addition of new indications of use, any regulatory changes, labeling requirements.
- Maintenance of approvals and registration.
- Renewal of licenses.
- Liaising between the Health authorities and the manufacturer.
With a strong knowledge of global regulations, guides manufacturers in successful preclinical and clinical testing and the study data compilation as per the medical device regulations. Support in obtaining various certifications and compiling for adequacy and accuracy of all other documentation that leads to market approval within strict timelines. We provide end-to-end Regulatory services for pre-and post-marketing activities of Medical Devices.
