Tanzania - Register Domestic In-Vitro Diagnostic (IVD) Device

Advertisement

Procedure

Apply In-Person:

1. To Register Domestic In-Vitro Diagnostic (IVD) Device, the applicant has to visit the Tanzania Medical Devices Authority Link
2. Applicants should obtain the application form from the office and fill it up with all the necessary information in it.
3. Applicants must carry photocopies and originals of all documents that are needed for completing this procedure.
4. Documents that are needed for completing this procedure are mentioned under the “Required Documents” section of this page.
5. The Fee for this procedure has to be provided as per the authority’s request.
6. Once the fee is paid, the receipt for the payment will be provided by concerned authorities, the receipt has to be kept safe by the applicant for future use.
7. The processing time for this procedure will be mentioned by the concerned authorities.
8. Applicant will get a notification via SMS or E-mail regarding the availability of the document, right after receiving the notification, the applicant can visit the office and get their document.
9. If there is no information regarding the license that needs to be provided, the applicant can visit the office and know the status of their application.

Advertisement

Required Documents

• Completed Application Form
• Covering Letter from the Applicants
• Power of Attorney
• Original or a copy of Label
• Marketing Authorization letter
• Product Specification and testing protocols

Office Locations & Contacts

Tanzania Medicines and Medical Devices Authority,
Physical Address:
P.O. Box 1253,
Dodoma or P.O. Box 77150,
Dar es Salaam, Tanzania.
Hotline: +255 22 2450512 / 2450751 / 2452108
Fax: Nō: +255 22 2450793
Email Address: [email protected]
Contact Link
Location Link
Official Link

Eligibility

• Any Individual or business owners who are willing to register their domestic in-vitro diagnostic (IVD) Device are eligible for this procedure.

Fees

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

Validity

• This license is valid for the period mentioned in it.

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

• Processing time for this procedure will be mentioned by the concerned authorities.

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

• Applicants must follow all instructions provided by concerned authorities properly.
• Applicants should make sure to provide genuine information while applying for this procedure.
• Applicants must complete their application form before submitting, incomplete applications will be rejected.
• If the Applicants cannot apply online, they can visit the office for In-person applications.

Required Information

• Name of the Applicants
• Product Manufacturing premises
• Postal Address
• Email Address
• Mobile Number

Need for the Document

• Registration is necessary for starting a domestic in-vitro diagnostic (IVD) Device business and undergoing any kind of transportation of domestic in-vitro diagnostic (IVD) Device in Tanzania, legally.

Information which might help

• If the Applicants seek to import the same brand that belongs to some other manufacturers, they have to provide various applications or different application forms for each manufacturer separately and the fee must be paid separately.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.

External Links

• Tanzania Medical Devices Authority Link

Others

More information which might help people.