MEDICAL DEVICE REGISTRATION AND APPROVAL IN Zanzibar

MEDICAL DEVICE REGISTRATION AND APPROVAL IN Zanzibar

General country-specific regulatory information is provided on this page for medical device registration and approval in Zanzibar
Last update: October 2023

Medical Device Regulations and Classification in Zanzibar

REGULATORY AUTHORITY:

Zanzíbar Food and Drug Agency (ZFDA)

 

CLASSIFICATION SYSTEM:

Both medical devices and IVDs are following this risk classification:

•Class A

•Class B

•Class C

•Class D

 

TIMEFRAME:

Official Timeline

Medical device registration: vary from 60 to 150 days depending on risk classification

IVD device registration: up to 270 days

 

SPECIAL REQUIREMENTS:

Local testing: certain diagnostics equipment such as analysers will require a local testing, but this is only requested once the reviewer is not satisfied with the presented data.

On-site inspection: an on-site inspection to a foreign manufacturing facility will be required for class B, C and D devices.

 

PRODUCT REGISTRATION MD:

From 200 US$ to 1000 US$ – depending on the class of the device 


PRODUCT REGISTRATION IVD:
From 100 US$ to 1000 US$ – depending on the class of the device 

 

LOCAL FEES (Manufacturer):

On-site inspection fees vary from USD 4000-8000 depending on the location of the manufacturing facility.

 

LICENSE VALIDITY

The issued license will be valid for 5 years. The renewal application must be submitted 90 days before the license expiry date.

 

LICENSE TRANSFER

Transferring license from one authorized representative to another is possible.

 

AUTHORIZED REPRESENTATIVE

A foreign manufacturer must appoint a local company that has obtained a medical device establishment license to become their authorized representative. Proof of official appointment shall be submitted to ZFDA.

 

ADDITIONAL INFORMATION

•Marketing authorization license will remain issued once the application for on-site audit is paid and submitted (conditional approval).

•Certain medical devices, due to low risk associated of their use, are exempted from the product registration requirement. Although exempt, a notification to ZFDA is still required.

Other Sub-Saharan African Countries: AngolaBeninBotswanaBurkina FasoBurundiCameroonCentral African RepublicChadComorosCongoDR CongoEquatorial GuineaEritreaEthiopiaGabonGambiaGhanaGuineaGuinea – BissauIvory CoastKenyaLesothoLiberiaMadagascarMaliMozambiqueNamibiaNigerNigeriaRwandaSenegalSierra LeoneSomaliaSouth AfricaSouth SudanSwazilandTanzaniaTogo

 

JUST SAY WHEN!

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And, in less than a minute, you can start your device-specific registration application and a complete country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

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