The article outlines the key points of the regulatory approach applied in Tanzania when it comes to medical devices intended to be marketed and used in the country.
Table of content
The Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to good review practices for the regulation of medical devices. The document provides an overview of the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance with the relevant regulatory requirements.
At the same time, the authority reserves the right to make changes to the guidelines and recommendations provided therein, should it be reasonably necessary to reflect corresponding amendments to the underlying legislation or changes to the respective principles.
Introduction
The TMDA intends to optimize regulatory performance by implementing Good Review Practices (GRevP) for medical devices. As a key aspect of good regulatory practices, GRevP enhances the medical device review process, ensuring applications meet high scientific and evidentiary standards for quality, safety, and performance.
The GRevP guidelines are created to offer structure to the complex assessment processes while providing recommendations to stakeholders, thus improving consistency and efficiency in the approval of medical devices. Although these guidelines are binding in their legal nature, they explain the current approach to regulatory review and can be updated to respond to advancements in the regulatory field, feedback from stakeholders, and innovations in regulatory processes.
Terms and Definitions
To ensure clarity, the guidelines provide the definitions of the key terms and concepts in order to assist in understanding the regulatory processes, including:
- Act: Refers to the Tanzania Medicines and Medical Devices Act, Cap 219.
- TMDA: Tanzania Medicines and Medical Devices Authority.
- Applicant: A person or company submitting a marketing authorization application.
- Application: The set of information provided by the applicant for the Authority’s evidence-based assessment.
- Assessor: A qualified personnel involved in the technical evaluation of medical devices.
- Assessment: A comprehensive, multidisciplinary evaluation of applications for quality, safety, and performance.
- Assessment Procedure: The methodology an assessor applies in processing an application.
- External Assessor: An assessor sourced from outside the TMDA.
- Good Review Practices (GRevP): The best practices for the medicinal product assessment and registration process.
- Medical Devices Vigilance: Activities aimed at detecting, assessing, and preventing device-related problems.
- Marketing Authorization: A legal approval for marketing a medical device in Tanzania, ensuring it meets safety and performance standards.
- Post Marketing Surveillance (PMS): Systems for monitoring medical devices post-registration.
- Quality Management System (QMS): Organizational infrastructure to control quality processes.
- Regulatory Convergence: The alignment of regulatory standards with international best practices.
- Transparency: The openness of policies, procedures, and decision-making processes to the public.
Regulatory Background
The TMDA, operating under the Ministry of Health, oversees the quality, safety, and effectiveness of medical devices and other health-related products. The agency enforces regulatory practices aligned with the Tanzania Medicines and Medical Devices Act, Cap. 219.
The adoption of GRevP guidelines addresses multiple regulatory aspects, including:
- Enhancing assessment of medical devices and in-vitro diagnostics,
- Improving practices for adverse event reporting,
- Strengthening the consistency and transparency in the assessment and registration processes and
- Providing clear guidance to applicants regarding TMDA’s internal procedures.
The present guidelines are intended to ensure a more cohesive and transparent review process through standardized operating procedures (SOPs) and assessment templates.
Key Areas of GRevP Implementation
The guidelines focus on several core areas to support a structured review and registration process:
- Implementation of Good Review Practices: The guidelines help structure the assessment process to ensure consistency and quality in every review cycle, thereby streamlining the path to approval for medical devices.
- Structural Organization of Medical Devices Assessment: TMDA aims to create an organized system that supports structured review, ensuring that every application is subjected to an objective, systematic assessment.
- Management of the Assessment Process: Effective project management principles are emphasized to maintain high standards and timeliness in reviews.
- Critical Thinking in Dossier Assessment: Emphasis on the need for assessors to apply critical thinking skills when evaluating dossiers, which helps in thoroughly understanding the product’s quality and potential impact.
- Effective Communication: The importance of open communication with applicants to clarify the procedures and expectations in the review process.
Objectives and Scope
The primary objective of the GRevP document is to set forth principles and guidelines for conducting medical device assessments within TMDA. It is primarily intended to establish a foundation for regulatory reviews but does not specify detailed procedural instructions.
This document aims to be complementary to other TMDA regulatory documents, thereby serving as a reference guide for assessors, applicants, and stakeholders. The scope of the guidelines encompasses the entire lifecycle of a medical device, from investigational testing to post-marketing surveillance.
It is applicable to new applications, updates to existing authorizations, and PMS activities to ensure that quality, safety, and performance standards are continuously met.
Conclusion
In summary, the present document establishes certain basic principles to be followed in order to ensure continued safety and proper performance of medical devices intended to be marketed and used in the country.
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