THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
ISO 9001: 2015: CERTIFIED
5th July, 2023
DRAFT GUIDELINES FOR HANDLING UNFIT MEDICAL DEVICES AND DIAGNOSTICS
- 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.
- 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.
- 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.
- Please send your comments to the Authority through e-mail firstname.lastname@example.org or the address below.
- The Guidelines will be available for comments until 30th August, 2023.
- We thank you for your continued cooperation.
- Please Click here to access the draft Guidelines
TEMPLATE FOR COMMENTS
|TITLE OF THE DOCUMENT||GUIDELINES FOR HANDLING UNFIT MEDICAL DEVICES AND DIAGNOSTICS|
|PART||PAGE NUMBER, SECTIONS||COMMENT AND RATIONALE|
Tanzania Medicines and Medical Devices Authority (TMDA),
Plot No. 56/1, Block E, Kisasa B Centre, Hombolo Road,
P. O. Box 1253, Dodoma.
Tell: +255 (26) 2961989/2061990 Email: email@example.com,
Website: www.tmda.go.tz, Toll free: 08001100834