Training Opportunities
TRAINING ON GOOD REGULATORY PRACTICES FOR STAKEHOLDERS AND DEALERS IN MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENT
TMDA would like to inform its esteemed stakeholders that the Authority has started to offer various training on good regulatory practices for all dealers in medical devices, diagnostics and laboratory equipment. The training targets all dealers and stakeholders including domestic manufacturers, importers, wholesalers, dealers in medical gases as well as healthcare facilities.
All training sessions will be facilitated by TMDA regulatory experts with a focus on educating stakeholders and dealers of medical devices, diagnostics and laboratory equipment on the information/data required to attain the necessary approval, permits or licenses when dealing with regulated products.
The training, which consists of 10 modules, aims at ensuring that all stakeholders are kept up to date on both national and international standards leading towards voluntary and streamlined compliance with the regulatory requirements.
Interested parties may opt to undertake the complete training package or select the modules that are most relevant to their activities. Furthermore, the Authority is offering tailor-made training for stakeholders who may need specific training outside the outlined modules.
Hence, the Authority is calling upon all interested parties to send a notice to TMDA, specifying their modules of interest via the following email address: medicaldevices@tmda.go.tz. The subject line of the email should be marked as follows: “TRAINING ON GOOD REGULATORY PRACTISES FOR DEALERS AND STAKEHOLDERS IN MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENT”.
Please note that, applicable fees shall be charged for the training as per schedule 4 of the Tanzania Medicines and Medical Devices (Fees and Charges) Regulation, 2021. into the country.
TRAINING MODULES ON THE REGULATION OF MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENT OFFERED TO TMDA STAKEHOLDERS
Module 1 |
REGULATORY REQUIREMENTS FOR DOMESTIC MANUFACTURERS, INNOVATORS AND NEW DEALERS IN MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENTThis module offers an overview of all the regulatory functions performed by TMDA and the general requirements that need to be fulfilled prior to the commencement of operation. It addresses the responsibilities of applicants as well as the role of the Authority in ensuring satisfactory customer service delivery without compromising the quality, safety and performance of products. |
Module 2 |
CLASSIFICATION AND GROUPING OF MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENTThis module provides an overview of the risk categorization of devices and its impact on the regulatory procedures for different risk classes. It highlights the wide scope of products that fall under the umbrella of “medical devices” and how these products can be classified accordingly. The module also touches on the concept of grouping of devices in order to determine the types of devices that can be submitted under a single application. The aim of this module is to assist dealers and applicants in correctly classifying and grouping their devices so as to ensure the correct set of data is submitted with their applications. This module will be interactive with live examples of different devices and how they can be categorized and/or grouped. |
Module 3 |
MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC DEVICES DOSSIER COMPILATION AND QUERY RESPONSE SUBMISSIONThis module provides all applicants with the critical knowledge on how to compile data for applications for market authorization of their products. It provides an overview of all relevant guidelines including clarifications on the specific data that is required for each section. The module will also touch on the market authorization process highlighting the critical areas that the Authority requires before making a final decision regarding applications. The trainees will also be taught to navigate the market authorization portal and how to respond to queries raised at different stages of the market authorization process. This module will contain mock dossier compilation exercises. |
Module 4 |
QUALITY AUDIT INSPECTION AND COMPLIANCE WITH ISO 13485This module provides an overview of ISO 13485 requirements and the importance of complying to the standard. It provides a step wise details of the quality audit process including the role and responsibilities of TMDA quality audit inspectors as well as the expected responsibility of facility owners and superintendents. The trainees will be taught how to establish and maintain an effective quality management system for their facilities as well as tips on how to comply to ISO 13485. This module will contain a mock quality audit inspection exercise. |
Module 5 |
INTRODUCTION TO GOOD DISTRIBUTION AND STORAGE PRACTISES (GDSP)This module offers an overview of the principles of good distribution and storage practises in relation to medical devices. It details to dealers the importance of practising these principles in ensuring the safe storage and delivery of devices. It highlights on the impact of poor or improper storage and distribution practises on the quality and performance of devices. The trainees will be taught how to establish an effective quality management system as well as tips on how to ensure continuous compliance to GDSP principles. |
Module 6 |
PREMISE INSPECTION AND LICENSINGThis module applies the principles learnt in module 5. The module outlines the premise inspection and licensing process including an overview of all relevant guidelines. The different types of premises shall be discussed including the specific information that is required to be provided for each premise. The module also offers a summary of the physical premise inspection process including an overview of the inspection checklist. It also touched on the role of the Authority as well as the rights and responsibilities of premise owners. The trainees will be taught how to identify areas that are appropriate for premises of medical devices based on the scope of activities that are planned. |
Module 7 |
IMPORT AND EXPORT OF MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENTThis module offers an overview of the importation and exportation of medical devices. It provides an explanation on the reasons for controlling devices that enter or leave the country. It also outlines the inspection process that is conducted at ports of entry before consignments can be released. The module also explains the different types of importation permits that are issued by the Authority as well as the products that require permits prior to their importation or exportation. The module also details on the criteria for special importation permits highlighting on when, how and why this procedure is applied. It will also touch on the steps that the Authority is taking to reduce/limit the use of special importation procedure. The trainees will be taught the specific information that is required to be submitted with their applications and how to respond to appropriately respond to queries raised during the process. |
Module 8 |
VIGILANCE AND POST MARKET SURVEILLANCE OF MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENTThis module gives an overview of the post market authorization procedures that are conducted by the Authority to ensure that the devices circulating in the market are safe and effective. The module will highlight on the relevant applicable guidelines and how the different PMS and vigilance programs are implemented. Trainees will be taught their responsibilities in relation to vigilance and surveillance of their products in the Tanzanian market. |
Module 9 |
RECALL AND DISPOSAL PROCEDURES FOR MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENTThis module applies the principles learnt in module 5. This module will cover the recall and disposal procedures for devices. It will highlight the role and responsibilities of all key players in the recall and disposal process. The trainees will be taught how to initiate recall and disposal procedures. They willl also learn how to effectively implement recall instructions issued by the Authority when the need to remove products from the market is necessary. |
Module 10 |
ADVERTISEMENT AND PROMOTION OF MEDICAL DEVICES, DIAGNOSTICS AND LABORATORY EQUIPMENTThis modules covers the overall control of advertisements and promotion of devices by TMDA. It explains why, how and when the Authority regulates the promotion of devices in Tanzania. It outlines the requirements and information that needs to be submitted in order for promotional materials to be circulated. The trainees will be taught the types of promotional materials that are regulated by the Authority and how to navigate the traders portal when making an application for approval of advertisements and promotion of medical devices. |