ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

5^th July, 2023

DRAFT GUIDELINES FOR HANDLING UNFIT MEDICAL DEVICES AND DIAGNOSTICS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) would like to inform our esteemed Stakeholders and the general public that, we have recently developed draft Guidelines for Handling Unfit Medical Devices and Diagnostics.
2. These guidelines have been prepared to provide guidance on conducting withdraw and recall of unfit medical devices and diagnostics basedon relative health risks and adverse events or adverse incidents that may occur to patients or users respectively.
3. The purpose of this notice is to inform the public that TMDA is inviting comments on this draft guidelines which will help to finalize it. Please compile your comments specifying the draft guidelines you are commenting on as per the template given below.
4. Please send your comments to the Authority through e-mail medicaldevices@tmda.go.tz or the address below.
5. The Guidelines will be available for comments until 30^th August, 2023.
6. We thank you for your continued cooperation.

TEMPLATE FOR COMMENTS

TITLE OF THE DOCUMENT	GUIDELINES FOR HANDLING UNFIT MEDICAL DEVICES AND DIAGNOSTICS
PART	PAGE NUMBER, SECTIONS	COMMENT AND RATIONALE

7. Please Click here to access the draft Guidelines