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Tanzania

My IQ Cert > Tanzania

Tanzania Medicines and Medical Devices
(Authority) TMDA (Tanzania)

Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health (MOH). TMDA which was formerly known as Tanzania Food and Drugs Authority (TFDA) was established in 2003 after enactment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 by the Parliament.

Classification of Medical Devices

CLASS

 

RISK LEVEL

 

DEVICE EXAMPLES

 

A

Low Risk

Surgical retractors/tongue depressors

B

Low- moderate Risk

Hypodermic Needles/suction equipment

C

Moderate – high Risk

Lung ventilator/bone fixation plate

D

High Risk

Heart valves / implantable defibrillator

Applicant

The applicant shall be a person who is a resident of Tanzania and must be licensed by TMDA as a medical device dealer. If the applicant is not resident in Tanzania, he/she shall appoint a Local Responsible Person (LRP) also referred to as Authorized Representative or Local Agent who must be a company incorporated in Tanzania and authorized by TMDA to deal in medical devices.

Routes for Marketing Authorization

There are two main routes for marketing authorization of medical devices, in-vitro diagnostic devices and laboratory equipment i.e. registration or notification.

Registration is the main route and is applicable to all class B, C and D medical devices and in-vitro diagnostic devices as well as select class A devices that possess the following characteristics:

 

  1. Active devices;
  2. Measuring function; and
  3. Sterile.

Notification is the marketing authorization route that is reserved for class A medical devices and in-vitro diagnostic devices that do not meet the criteria for registration process.

Application process

All applications shall be submitted online through the TMDA Trader’s Portal. An application consists of documentation in electronic form, samples and fees. The applicant should have the following information before submitting the dossier to TMDA: –

  1. Class of the device
  2. Intended purpose of the device
  3. GMDN code and term
  4. Conformity assessment certification
  5. Declaration of conformity

Payment

Process

 

Fees in USD

 

Processing time (in days)

 

Notification

100

5

Registration class A

500

45

Registration class B

2500

45

Registration class C, D

2500

45

Major variation

300

10

Minor variation

150

10

Retention – registered devices

200

–

Retention – notified devices

50

–

Documents Required for Tanzania Medical Device Registration

  • Covering letter
  • A duly filled in application form. Submission shall be both in hard copy and in electronic form on a CD-ROM
  • A table of contents listing all sections of the dossier and documents and their corresponding page numbers
  • Copies of referenced literature and other supporting documents
  • Two samples of the commercial pack(s)
  • A non-refundable application fee for registration of medical devices in Tanzania as provided in the Fees and Charges Regulations currently in force.
  • Apply through the Tanzania Medicines and Medical Devices Authority (TMDA).
  • Appoint a local authorized representative if you are a foreign manufacturer.
  • Class A (Low-Risk) Devices:
  • Basic Information:
    • Copies of labels for the device, primary/secondary components, and accessories.
    • Instructions for use.
    • Patient information leaflet (if applicable).
    • Sterilization validation report (for sterile devices).
    • Certification for measuring function (if applicable).
    • Certification for electrical safety (for active devices).
  • Possible Exemption: Class A devices with low risk uses may be exempt from registration. Check the Second Schedule of the Regulations for details.
  • Class B, C & D (Higher-Risk) Devices: Include all basic information required for Class A devices.
  • Additional Information:
    • Description of the device, materials used, and features.
    • Intended uses and medical conditions it addresses.
    • Sales history in other countries and any reported issues.
    • Risk assessment plan.
    • Quality management plan.
    • Manufacturing process details.
    • Standards followed for design and manufacturing.
    • Summary of supporting studies (pre-clinical, clinical, etc.).
    • Biological safety evidence (if applicable for animal/human tissue).
    • Details on near-patient testing (if applicable).
    • Bibliography of relevant publications.
    • Copy of the quality management system certificate.