Tunisia - Registration of Medical Device or In Vitro Devices (IVDs)

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Procedure

The Ministry of Public Health regulates the importation and registration of medical devices in Tunisia through the Directorate of Pharmacy and Pharmaceuticals (DPM).
How to apply

1. For application for registration of medical device, the applicant has to book an appointment at the Directorate of Pharmacy and Pharmaceuticals (DPM) via the website. . DPM
2. Duly filled registration form, available for download on the DPM website Registration form
3. Send the registration form to the following email address: [email protected] once registered, a password will be communicated via email enabling the access to the ‘e-booking’ portal.
4. Book an appointment with the DPM via the website then the applicant should visit the DPM office on the scheduled date.
5. Approach the services desk and request for the application forms fill them accurately, attach all the required dossiers and submit them to the attending official
6. Your application will be sent to a specialized medical committee appointed by the DPM for pre-clinical and clinical assessment, if it pass the assessment
7. Your application will then be sent to the National Laboratory of Medicinal products Control (LNCM) which assess the quality data of the medical product, if it pass this stage
8. Your application will then be sent to the Technical committee of pharmaceutical specialities which advise the ministry of health with regards to the findings of the application
9. If all the information are in order you will be issued with the licences by the register upon payment of all the required fees

Note

• An authorized representative is required.
• In case of appointment delay, missing documents or unfilled forms, scheduling another appointment will be mandatory.

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Required Documents

• Accurately filled application forms
• Sample of the product (if applicable)
• Documentation/Dossier
• Bank slip receipt( prove of payment)

Office Locations & Contacts

Pharmacy and Drug Directorate (DPM)
31, Rue de Khartoum 1002 Tunis - Belvedere Tunisia
Telephone: (+216) 71 78 31 95/71 79 06 39/71 78 14 87
Fax: (+ 216) 71 79 78 16
Secretariat of the National Bureau of Narcotics: tel. / fax: (+ 216) 71 79 52 50.
Email: [email protected]
Email: [email protected]

Ministry of Health
Address: Bab Saadoun 1006 Tunis
Telephone :( 216-71) 577 000
Fax: (216-71)577 000
Website: National portal

Eligibility

• Local and foreign manufactures
  

Note

• An authorized representative is required

Fees

Explain the fees structure which is required for obtaining the certificate/document.

Validity

• The licences is valid for 5 years and renewable afterwards
• An import license expires after one year, and renewable afterwards

Documents to Use

• Registration form
  
• Application form for registration of implantable medical device
  
• List of implantable medical device

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Within 30 days, if all the information are in order .

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• All medical Devices require to obtain an Authorization for Market Commercialization (AMC), issued by the Directorate of Pharmacy and Pharmaceuticals (DPM) of the Republic of Tunisia.
• Heavy medical equipment, such as CT or MRI scanners, must also obtain a separate license from the Ministry of Health (MOH). The registration process is conducted through a local agent, and documents should be submitted directly to the DPM office in Tunisia
• There is no official classification system for medical devices. All imported products are classified by the Department of Commerce for technical inspection into categories A, B, and C.

Required Information

Proprietary/brand name

• Brief description of the device
• Intended use and method of use
• Medical specialty in which the device is used
• Contraindications, warnings, precautions, potential adverse events
• List of accessories and other devices or equipment to be used in combination with the device.
• Variations in shape, style or size of the device, if applicable
• Labelling details
• Packaging description including pack sizes
• Recommended storage conditions

Need for the Document

The objective of registration of medical product /device by the Directorate of Pharmacy and Pharmaceuticals (DPM) of the Republic of Tunisia is to protect patients and the general public by ensuring that all medicinal products circulating in the country are

• Safe
• Efficacious
• Of good quality
• Suitable/appropriate to the local market
• Therapeutically relevant to the health needs of the population (for community health diseases)

Information which might help

• Any regulatory or legal question is sent to the following address: [email protected]
• If you have any legal or regulatory question regarding the registration of the medicinal product for human use, please send your question to: [email protected]

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Republic of Tunisia
ministry of health

Others

More information which might help people.