Qatar Medical Device Registration Process | MoPH PDCD Guide
This report summarizes the key regulatory requirements for placing medical devices on the Qatari market, as stipulated by the Ministry of Public Health (MoPH), specifically the Pharmacy and Drug Control Department (PDCD). The regulatory framework differentiates between implantable and non-implantable devices, with the latter constituting the majority of imports. Understanding this pathway is crucial for successful market entry and supply chain continuity.
Regulatory Authority & Mandatory Local Representation
Regulatory Body: The Qatari Ministry of Public Health (MoPH), acting through the Pharmacy and Drug Control Department (PDCD), is the sole regulatory authority.
Local Authorized Representative (AR): Foreign manufacturers cannot interact directly with the MoPH. It is mandatory to appoint a locally registered Qatari company as your Authorized
Representative (AR). This AR acts as your legal agent, responsible for all communications, submissions, and obtaining the necessary permits from the MoPH.
Device Classification & Key Pathways
The regulatory pathway is determined by the device type:
Device Category | Regulatory Requirement | Key Characteristics |
Implantable Devices | Full Registration | Mandatory pre-market registration with the MoPH before any import/sale. |
Non-Implantable Devices & Consumables | Import Permit (per Shipment) | Required prior to each shipment. This is the standard route for most general medical devices and supplies. |
Core Prerequisite: Reference Market Approval
For both pathways, a fundamental requirement is that the device must possess prior authorization from a reference market regulator recognized by the Global Harmonization Task Force (GHTF). Approved jurisdictions include:
USA (FDA 510(k) or PMA)
European Union (CE Marking)
Japan (PMDA)
Canada (Health Canada)
Australia (TGA)
This approval forms the basis for the technical review in Qatar.
Required Documentation for Import Permit (Non-Implantable Devices)
Your appointed Local AR must submit the following documents to the MoPH for each import permit application:
1. Certificate of Free Sale (CFS): Issued by the health authority in the country of manufacture. Must be legalized by the Qatari Embassy/Consulate in that country.
2. Commercial Invoice & Packing List: Specific to the intended shipment, detailing products, quantities, and values.
3. Certificate of Origin: Standard document for customs clearance.
4. Technical Dossier: Containing:
ISO 13485 certificate of the manufacturing facility.
Declaration of Conformity (for CE mark) or FDA approval evidence.
Instructions for Use (IFU) in both English and Arabic.
Essential product specifications and labeling.
5. Local Agent's Credentials: A copy of the AR's valid Qatari Commercial Registration (CR) and Medical Store License.
Standard Process Flow
Step 1: Appointment of Local AR
Formalize the relationship with a chosen Qatari agent.
Execute and legalize a Letter of Appointment/Mandate.
Step 2: Dossier Preparation & Submission
The Local AR compiles the complete documentation package.
Submission is made via the MoPH's Electronic System.
Step 3: Review & Permit Issuance
The PDCD reviews the submitted application and verifies compliance.
Upon approval, an Import Permit is issued.
This permit is presented for customs clearance to facilitate the entry of the shipment.
Recommendations & Next Steps
Identify and Contract a Qualified Local AR: This is the most critical first step. Ensure the agent has a strong track record with the MoPH and relevant sector experience.
Audit Documentation: Assemble and review all required documents, paying special attention to the legalization of the Certificate of Free Sale and the preparation of Arabic IFUs.
Plan for Lead Time: Factor in the time for document processing, MoPH review (typically several weeks), and permit issuance into your supply chain logistics for each shipment.
Maintain Compliance: Ensure your reference market approvals (e.g., CE Mark, FDA) remain valid, as any lapse will impact your ability to obtain Qatari import permits.
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Disclaimer: This report is a summary based on current MoPH regulations, which are subject to change. It is recommended to verify the latest requirements with your Local Authorized Representative or the MoPH directly prior to initiating any formal application.
