Tanzania - Renew Registration of Medical Device Including In-Vitro Diagnostic Device

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Procedure

Apply In-Person:

1. Application for renew registration of medical device including In-Vitro Diagnostic Device in Tanzania is available in Tanzania Medicines and Medical Devices Authority contact link
2. Applicant must provide all the information that is requested in the application form.
3. Applicant should make sure to carry both photocopies and originals of all necessary documents for completing this procedure.
4. Documents that are needed for completing this procedure are mentioned under “Required Documents” section of this page.
5. Applicant should attach all needed documents (photocopies and originals if necessary) along with the application form before submitting it in the office.
6. Fee for this procedure has to be paid as per the authority’s request.
7. If all these steps were followed properly by the applicant, the approval will be provided within 1 week.
8. If there is no information regarding the availability of the approval either through SMS, E-mail or a phone call, then the applicant can visit the office to know status of their application after 1 week.

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Required Documents

• Completed Application Form
• ID Proof – National ID/Passport/Driving License
• Ownership of the premises or lease agreement
• Clinical degree certificate or practitioner license
• TIN Certificate

Office Locations & Contacts

Tanzania Medicines and Medical Devices Authority,
Nelson Mandela Rd, Dar es Salaam, Tanzania
Contact No: +255 222 450 512
Contact link
Location link

Eligibility

• Any certified dental professional or practitioner who is willing to start a new clinic or any existing premises without proper registration is eligible.

Fees

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

Validity

• Registration of a medical device including In-Vitro Diagnostic Device is valid for 2 years.

Documents to Use

Please attach some documents that can be used by people e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The processing time for this procedure is 1 week.

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.gIn 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 make sure to follow all instructions that are provided by concerned authorities.

Required Information

• Name of the applicant
• Age
• Date of Birth
• Address
• Mobile Number
• Email Address
• Signature

Need for the Document

• Registration of a medical device including In-Vitro Diagnostic Device is necessary for operating a clinic legally in Tanzania.

Information which might help

Please provide some information that might help

Other uses of the Document/Certificate

Please mention what are the other uses of the document/certificate
e.g. Birth certificate can be used as proof of identity

External Links

• Tanzania Medicines and Medical Devices Authority (TMDA HQ) link

Others

More information which might help people.