Safety Performance of Medical Devices

Who is responsible for safety and performance of medical devices and diagnostics in Tanzania
  • Registrant
    1. Registrant of the device in order to ensure that the product continuously maintains its quality, safety and performance profile during its life cycle.

    2. They are required to monitor and report any adverse event and/or incident related with the use of their product.

    3. If the registrant is based outside the country, local responsible person will take charge of the responsibilities of the registrant.

  • The Authority
    1. Continuously monitors quality, safety and performance through vigilance and post marketing surveillance activities.

    2. Inform the public in case of any safety, quality and performance concerns regarding medical devices and diagnostics.

Who should report
What to report

User should report adverse events/incidents that meet EITHER of the following criteria;

  • 1 An adverse event/incident related to a medical device or IVD that has led or may lead to mild or moderate or serious threat to public health or death or serious injury; or
  • 2 The medical device is associated with the adverse event.
How to report

Adverse event/Incident could be reported in a medical devices adverse event/incident orange reporting form for health facilities, patient/consumers, manufacturers as well as importers/suppliers


Report a medical device/diagnostic problem

(Consumer/Health Facility)

Toa taarifa za madhara na matukio ya vifaa tiba na vitendanishi

(Wagonjwa/Vituo vya Afya)

Report a medical device/diagnostic problem


Report a medical device/diagnostic problem


The form should be appropriately filled in and submitted via postal mailing, electronically (email or online), telephone or physically to TMDA. Manufacturers may submit the form via their local technical representatives.

When to report

Users are encouraged to report all adverse events/incidents as soon as possible. The adverse event/incident should be reported under the following timeline:

Adverse event(s)/Incident(s) Report within
Adverse event/incident that results in death, serious injury or represent serious public health threat 24 hours
All other adverse events/incidents 30 days
Where to report

The adverse event/incident report for consumers/patients and user facilities/health professionals should be sent to:

  • a) TMDA Headquarter Offices.
  • b) TMDA Zonal Offices.
  • c) Medical Device Vigilance Focal Persons in the respective health facilities.
  • d) In-charges of the health facilities (Dispensaries, Health Centres, Hospitals).
  • e) Superintendents of the Community Pharmacies.

Manufacturers/importers/suppliers should send the report of adverse event/incident to:

Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
P. O. Box 1253,
Plot No. 56/1, Block E, Kisasa B Centre, Swaswa Road, Adjacent to Martin Luther School, DODOMA
P.O. Box 77150,
Off Mandela Road, Mabibo-External, DAR ES SALAAM
Tel: +255-22- 2450512/2450751/2452108 +255 68 445222/777 700002/685 701735
Fax: +255-22-2450793
Toll free number: 0800110084