Our Services

Core Services (12 tasks in a single service - Fixed pricing by classification)

1. Classifying the medical device(s) and accessories that need to be registered in the KSA & GCC market and determining the closest registration option (medical device, in vitro diagnostic medical device, drug, or combination product).

2. Studying the feasibility of bundling products together.

3. Determining the type of combined devices.

4. Determining the medical device category.

5. Determining the device’s risk level.

6. Accurately identifying the applicable classification rules for each device.

7. Evaluating the technical file documentation in accordance with local and international standards.

8. Requesting additional documents/evidence from the manufacturer if required.

9. Reviewing test reports and results.

10. Direct communication with the client in case of missing requirements.

11. Following up on the application and reminding the client if the process is pending due to missing files.

12. Issuing a final scientific and technical report clarifying the eligibility, safety, effectiveness, performance, and quality of the medical device and its technical files.

Additional Services (Each Service is assessed and quoted individually)

1. Assessing the manufacturer’s eligibility in medical devices/products.

2. Conducting global market research for the proposed device type.

3. Studying Specific market demand for the medical device.

4. Providing scientific research supporting the device’s results.

5. Offering technical consultancy for manufacturers on regulatory and marketing process development.

6. Reviewing and auditing test results.

7. Verifying the competence and accreditation of certification/testing providers.

8. Suggesting alternative or equivalent medical devices if available.

9. Conducting product feasibility studies.

10. Providing the medical product’s history.

11. Consulting on any part of the technical file.

12. Conducting similar studies, articles, and state-of-the-art literature.