Oman Medical Device Registration: An Overview

Oman is now a thriving centre for the medical device industry. It has modernized its healthcare system by investing in the industry. The huge demand in the healthcare sector attracts major players to expand their market presence in Oman.

As a medical device regulatory consultant in Oman, we assist manufacturers of various borders in regulatory compliance, allowing them to place their medical devices in various markets according to the required medical device regulations.

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What are the Medical Device Regulation in Oman?

Regulatory Authority: In Oman, medical devices are regulated by the Directorate General for Pharmaceutical Affairs and Drug Control, under the Ministry of Health.

Classification System: Class A, B, C and D

Timeframe: The approval process can take up to two years.

License Validity: Licenses issued in Oman expire after five years.

Authorized Representative: A local authorized representative is required.

What is the Process of Oman Medical Device Registration?

  1. Appoint an Omani-authorized representative  
  2. Complete the application form and Submission of all required documents. 
  3. After approval, the applicant will receive the registration certificate.

What Documents Are Required for the Oman Medical Device Registration?

  • Application Form
  • CE certificate
  • Free Sales Certificate
  • QMS certificate
  • User Manual, Labels or Package Inserts
  • Declaration of Conformity

What Is the Role of the Operon Strategist in Oman Medical Device Registration?

Operon Strategist specializes in guiding manufacturers through Oman’s complex medical device regulations. Our services include classification advice, application support, and ensuring compliance with the Directorate General for Pharmaceutical Affairs and Drug Control’s requirements. We facilitate the approval process, assist in appointing a local representative, and ensure accurate documentation for registration.

Why Choose Operon Strategist?

  1. Expertise in Oman’s Regulations: We specialize in Oman’s medical device regulations, offering in-depth knowledge and guidance for smooth compliance.
  2. Efficient Process Management: We streamline the registration process, ensuring accurate documentation and efficient submission to expedite approvals.
  3. Local Representation Assistance: We help appoint local representatives, ensuring smooth communication and compliance with Oman’s regulatory authorities.
  4. Dedicated Support: Our commitment extends beyond registration; we provide ongoing guidance to maintain compliance in Oman’s market.
  5. Experienced Consultants: Our team comprises experienced consultants well-versed in the intricacies of medical device compliance in Oman.
  6. Proven Track Record: Operon Strategist has a history of successfully assisting manufacturers in entering Oman’s thriving medical device market.

Choosing Operon Strategist means partnering with a dedicated team to navigate Oman’s regulatory landscape, ensuring efficient and compliant medical device registration processes.

Ready to start your medical device registration process in Oman? Contact Operon Strategist today to discuss your project requirements and streamline your entry into Oman’s burgeoning healthcare sector.