REGULATION OF IN-VITRO DIAGNOSTICS AND LABORATORY EQUIPMENT

PUBLIC NOTICE

Date: 04th April, 2017

REGULATION OF IN-VITRO DIAGNOSTICS AND LABORATORY EQUIPMENT

  1. Tanzania Food and Drugs Authority (TFDA) is an Executive Agency under the Ministry of Health, Community Development, Gender, Elderly and Children established under the Tanzania Food, Drugs and Cosmetics Act, Cap.219.

  1. You may recall that, the Private Health Laboratories Board (PHLB) under the Ministry responsible for Health was responsible for regulation of in-vitro diagnostics and laboratory equipment, but nevertheless, this responsibility has now been shifted to TFDA.

  1. We would therefore like to inform all stakeholders involved in the manufacture, importation, distribution and sale of in-vitro diagnostics and laboratory equipment that following the approval of the Tanzania Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015, GN 315, TFDA is now responsible for the regulation of these products.

  1. In view of this, we wish to request all stakeholders to submit details of in-vitro diagnostics and laboratory equipment they are currently dealing with in Tanzania for notification purposes. The notification should be done through notification forms available at all TFDA offices and on the website (www.tfda.go.tz). The notification period will start with effect from the date of this notice and shall be ending on 30th April, 2017.

  1. Beginning May 1st, 2017, all permits for importation of such products will be issued to notified products only.

  1. Please be informed that, several guidelines in the area of in-vitro diagnostics (IVDs) and laboratory equipment have also been developed to delineate requirements specific for this category of products as follows:-

  • Guidelines for Submission of Documentation for Registration of In-Vitro Diagnostics, 2016;
  • Guidelines for Importation and Exportation of Medical Devices including IVDs, 2016;
  • Guidelines for Medical Devices Vigilance System in Tanzania, 2016;
  • Guidelines for Good Distribution Practices of Medical Devices, 2011; and
  • Guidelines for application of permits to deal with business of the medical Devices, 2011.
  1. All stakeholders are advised to access these guidelines from TFDA website in order to familiarize with the new requirements.

DIRECTOR GENERAL
Tanzania Food and Drugs Authority,
Nelson Mandela Road, Mabibo External,
P.O. BOX 77150,
DAR ES SALAAM.
Tel. No. +255: 658 445222, 685 701735, 777 700002
Fax No.: +255 22 2450793,
E-mail: info@tfda.go.tz
Website: www.tfda.go.tz

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