Medical Device Regulatory Requirements in Tanzania

Regulatory Authority Tanzania Food and Drug Authority
Regulatory Authority Website Link Click Here
Device Classification A,B,C,D
Medical Device Regulations The Tanzania Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015 | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations In Vitro Diagnostics Devices Guidelines
Device Classification Guidelines Rules for classification are prescribed in the First Schedule of the Tanzania Medicines and Medical devices (Control of Medical Devices) Regulations, 2015. These rules are based on international practices and are in line with the rules of the Global Harmonization Task Force (GHTF). | Click Here
Registration Process Guidelines on Submission of Documentation for Registration of Medical Devices | Click Here
Registration Timeline Around 8 to 9 months
Requirement of Authorized Representative Yes
Language Requirement Labels must be in English Language
Fees for Submission

Fees and Charges for Medical Devices Premises Licensing and Compliance

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Post Market Surveillance

Guidelines for Medical Devices Vigilance System in Tanzania

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Reportable Incidents

The AE led to one of the following outcomes:
i. Death of a Patient, User or other Person;
ii. A serious injury or serious deterioration to a patient, user or other person, including:
(a) A life-threatening illness or injury,
(b) Permanent impairment of a body function,
(c) Permanent damage to a body structure and
(d) A condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure; and
iii. A near adverse event

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Adverse Event Reporting Timelines

For the Adverse event/incident that results in death, serious injury or represent
serious public health threat must be reported immediately within 24 hours by
phone, fax or email followed by detailed incident report within 15 calendar days.
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Recalls

Recall of Medical Devices, In vitro Diagnostics & Laboratory Equipment

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Advertising and Promotions

Section 68 of the Tanzania Medicines and Medical Devices Act Cap.219 restricts the promotion and advertisement of medicines, medical devices, invitro diagnostics and biocidals unless approved by the Authority.Section 68 of the Tanzania Medicines and Medical Devices Act Cap.219 restricts the promotion and advertisement of medicines, medical devices, invitro diagnostics and biocidals unless approved by the Authority.

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Additional Information

The registration of a medical device shall be valid for five (5) years unless suspended or revoked by TMDA or terminated by the registrant.
Contact Phone +255 22 262961989
Contact Email info@tmda.go.tz
Contact Address P.O. Box 1253, Dodoma or P.O. Box 77150, Dar es Salaam, Tanzania.
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 06/Oct/2025

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