ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

18^th October, 2023

INVITATION FOR EXPRESSION OF INTEREST (EOI) FOR SHORTLISTING EVALUATORS OF MEDICAL DEVICES AND DIAGNOSTICS

1. The Authority invites expression of interests (EOIs) from qualified Tanzanians to be engaged in the evaluation of applications for marketing authorization of medical devices and diagnostics for the financial year 2023/2024.
2. The scope of assignment shall be but not limited to the evaluation of medical devices and in vitro diagnostics dossiers, focusing on the following technical areas: -
   1. Ensuring rational use of medical devices through the assessment of product information including device details, product labelling and instructions for use; and
   2. Ascertaining the quality, safety and performance of medical devices and diagnostics through the assessment of summary technical documentation to include;
      1. The device features;
      2. Evidence of Conformity to Essential Principles;
      3. Design and Manufacturing information;
      4. Device specifications, verification and validation;
      5. Biocompatibility studies;
      6. Clinical evidence or performance evaluation;
      7. Analytical performance characteristics for In Vitro Diagnostics;
      8. Device stability; and
      9. Risk Analysis Reports.
3. The minimum qualification requirements in order for the EOIs to be considered is a bachelor degree in Pharmacy; Medical/Health Laboratory Sciences, Biomedical Engineering, Human or Veterinary Medicine, Molecular Biology and Biotechnology.
4. Eligible consultants or experts are invited to indicate their interest in providing the above-mentioned services by providing evidence of their qualification as follows: -
   1. A cover letter confirming compliance to eligibility including a description of their experience in undertaking similar assignment in the last year;
   2. A detailed CV indicating relevant experience;
   3. Full name and contacts of at least three referees who will be contacted during the review of the EOIs; and
   4. Certified copies of a degree certificate and registration evidence from relevant professional body (ies).
5. Expression of interest documents should be submitted in physical to any of the TMDA offices in a plain envelope clearly marked “EXPRESSION OF INTEREST (EOI) FOR EVALUATION OF MEDICAL DEVICES” addressed to the Director General, Tanzania Medicines and Medical Devices Authority, Plot No. 56/1, Block E, Kisasa B Centre, Hombolo Road, P. O. Box 1253, Dodoma – Tanzania.
6. Alternatively, the EOIs may be submitted via the following email addresses with the subject title “EXPRESSION OF INTEREST (EOI) FOR EVALUATION OF MEDICAL DEVICES”: medicaldevices@tmda.go.tz or info@tmda.go.tz.
7. The deadline for submission is on Friday 17th November, 2023 at 15:30 hours. Late submission of Expression of Interest shall not be accepted for shortlisting irrespective of any circumstances.
8. For more information, please contact the Authority through the following email address medicaldevices@tmda.go.tz.