Tanzania - Registration of medical devices or in vitro diagnostics devices (IVDs)

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Procedure

Apply In-Person:

1. Application for registering of Medical Devices or In vitro diagnostics devices (IVDs) is available in Tanzania Medicine and Medical Devices Authority contact link
2. Applicant must provide all necessary information in the application form.
3. Applicant should make sure to carry both photocopies and originals of all documents that are needed for completing this procedure.
4. Documents that are needed for completing this procedure is mentioned under “Required Documents” section of this page.
5. Applicant must attach photocopies of all documents along with the application form while submitting it at the office.
6. Downloadable application form is available in the following link
7. Fee for this procedure has to be paid as per authority’s request.
8. If all the above-mentioned procedures were followed properly by the applicant, the registration will be done within 260 days.
9. Applicant will be notified regarding the availability of registration document via SMS or Email.
10. After getting the notification, applicant can visit the office to collect their document.
11. Applicant can also visit the office in between to know status of their application.
    

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Required Documents

• Application form for registration of Medical Devices or IVD
• Cover Letter that is addressed to the Director General
• Technical File
• Medical Device / In vitro Diagnostics sample
• Stamp Bank Deposit slip
• Contact Details of Applicant
• Certificate of Power of Attorney
  

Office Locations & Contacts

Tanzania Ministry of Health, Community Development, Gender, Elderly and Children
Location: Dar es Salaam
Address: 57PV+G4W, Dar es Salaam, Tanzania
Contact: (+255) 222 342 000
Contact link
Location link

Tanzania Medicine and Medical Devices Authority HQ
Location: Dar es Salaam
Address: Nelson Mandela Rd, Dar es Salaam, Tanzania
Contact: (+255) 752 063 213
Contact link
Location link

Eligibility

Citizens of Tanzania and Permanent residents of Tanzania who are manufacturers of Medical Devices or IVDs in Tanzania or abroad are eligible.

Fees

Fee for this procedure has to be paid as per authority’s request.

Validity

This certificate of registration is valid for 5 years.

Documents to Use

Downloadable application form is available in the following link

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

The processing time for this procedure is within 260 days.

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

• Applicant must provide genuine information while applying for this procedure.
• Applicant should follow all instructions provided by concerned authorities properly.
• If any other additional documents are requested by concerned authorities during the application process, the applicant must provide them.
  

Required Information

• Property/Brand Name
• Brief Description of the device
• Category of the Device
• Intended use and methods 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

This document is necessary for manufacturing and selling any medical device or IVD in Tanzania.

Information which might help

TMDA is responsible for getting all IVD and other Medical Devices registered in Tanzania.

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

• Tanzania Ministry of Health, Community Development, Gender, Elderly and Children link
• Tanzania Medicine and Medical Devices Authority link
  

Others

More information which might help people.