Overview on Medical Device Registration in Qatar

Regulatory Authority

Ministry of Public Health

Link for Regulatory Authority 

https://www.moph.gov.qa/english/Pages/default.aspx

Local Regulation

Classification of Medical Devices 

Class I, IIa, IIb, III and IV

Listing or Registration Requirements

No registration required.

• Import license should be obtained by AR. Registration in Qatar requires prior approval in one of the following GHTF markets: Australia, Canada, Europe, Japan, or the USA.
• Generally, medical device or IVD classification in the reference market will determine the class of device.

Documents Required for Qatar Medical Device Registration

• Copy of applicant Qatar ID card.
• Copy of Commercial License.
• Copy of commercial registration.
• Copy of establishment ID card.
• Fill out the form to be submitted at MoPH.
• Attach all the required documents PMS not required
• Pay appropriate fees.

Registration Timeline:

Registration Fee:

License Validity:

Special Labelling Requirements:

Additional Comments

Medical devices must be authorized by one of the founding members of the Global Harmonization Task Force (GHTF) to obtain market access. A local authorized representative is required to obtain an import permit.

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk