Tanzania - Obtain Medical Device Manufacturing Permit

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Procedure

Apply In-Person:

1. Application form for obtaining Medical Device manufacturing permit in Tanzania is available in Tanzania Medicines and Medical Devices Authority contact link
2. Applicant must provide all information that is necessary in the application form.
3. Applicant should make sure to carry photocopies and originals of documents that are necessary for completing this procedure.
4. Documents that are needed for completing this procedure are mentioned under “Required Documents” section of this page.
5. Applicant must attach photocopies of all documents (whichever is necessary) along with the application form while submitting the form at the office.
6. Fee for this procedure is TZS 200,000/- as annual dealers fee for medium scale manufacturer and TZS 300,000/- as annual dealers fee for large scale manufacturer.
7. If all the above-mentioned procedures were followed properly by the applicant, the permit will be provided within 1 to 6 working days.
8. Applicant will be notified regarding the availability of the permit. After receiving the notification, the applicant can visit the office for collecting their permit.
9. If there is no information regarding the permit is provided by concerned authorities, applicant can visit the office to know status of their application.

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Required Documents

• Certified certificate of Incentives
• Memorandum and Articles of the Association
• Environmental Clearance Certificate
• Scoping Report Approval Letter
• Plan Layout
• TMDA Invoice
• Bank Slip
• TMDA receipts

Office Locations & Contacts

TMDA
Location: Dar es Salaam
Address:
TMDA HQ,
P.O.Box 77150,
Dar es Salaam,
Tanzania
Contact: (+255) 222450512 / 2450751 / 2452108
Fax No: (+255) 222450793
Email Address: [email protected]
Contact link
Location link

Eligibility

• Citizens of Tanzania and permanent residents of Tanzania who are willing to engage in Medical Device Manufacturing in Tanzania are eligible.

Fees

• Fee for this procedure is TZS 200,000/- as annual dealers fee for medium scale manufacturer and TZS 300,000/- as annual dealers fee for large scale manufacturer.

Validity

• The permit is valid for 5 years.

Documents to Use

Please attach 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 to 6 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 make sure to follow all instructions as mentioned by concerned authorities properly.

Required Information

• Full Name
• Date of Birth
• Residential Address
• Nationality
• Address of the manufacturing premises

Need for the Document

• This permit is necessary for manufacturing medical device in Tanzania.

Information which might help

• Traders who wish to manufacture drugs, food, cosmetics and medical devices must register their factory/premise with TFDA and subsequently obtain business license.

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 Medicine and Medical Devices Authority link

Others

More information which might help