The article describes the approach to be followed when it comes to the way the assessment process should be managed, as well as the matters related to marketing authorization and quality audits products should undergo in order to be allowed for marketing and use 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.
Managing the Assessment Processes
According to the guidance, the management of assessment processes involves clearly defined roles and responsibilities for both applicants and the regulatory authority, as well as understanding the various types of review processes involved.
In particular, applicants are expected to be knowledgeable about international regulatory requirements and specific mandates of the TMDA.
Their responsibilities include:
- Submission of Authentic Documents: Providing genuine and complete scientific documents to support their applications.
- Timely Submissions: Ensuring all additional data or required documents are submitted within the specified deadlines.
As further explained by the authority, for marketing authorization, applicants must:
- Maintain Compliance: Ensure their products meet all requirements to remain listed in the register of approved medical devices and in-vitro diagnostics.
- Submit Variations: Inform the Authority of any changes in line with the variation guidelines.
- Renew Registrations: Renew their product registrations every five years.
- Conduct Market Surveillance: Monitor the product post-authorization to ensure ongoing compliance.
- Report Issues Promptly: Notify the Authority immediately upon detecting any problems related to a registered device, such as serious manufacturing defects that may endanger public health.
- Handle Recalls: Manage device recalls efficiently and in accordance with regulatory guidelines.
- Provide Support: Offer technical support and services to users of registered devices.
The authority also mentions that in case the applicant is not a resident of Tanzania, they must appoint a Local Responsible Person (LRP). Under the general rule, the authority is responsible for ensuring the quality, safety, and performance of medical devices and in-vitro diagnostics by allocating adequate and competent human resources to implement Good Review Practices (GRevP).
Regulatory experts are expected to:
- Adhere to GRevP: Follow pertinent GRevP during assessment reviews unless a deviation is justified and documented.
- Document Deviations: Any departure from GRevP must be adequately justified and recorded.
Managers within the Directorate of Medical Devices (DMD) have specific responsibilities:
- Develop Tools: Create, implement, update, and enforce tools necessary to execute GRevP.
- Communicate Instructions: Provide specific guidance when deviations from GRevP are appropriate.
- Training: Conduct training needs assessments and plan suitable in-house training programs.
- Mentorship: Oversee the mentoring of regulatory experts to ensure they are proficient in their roles.
- Policy Advice: Advise management on GRevP content, policies, and recommend appropriate training courses.
According to the guidance, the assessment processes encompass:
- Marketing Authorization (MA);
- Quality Audit Desk Review;
- Importation and Exportation Processes; and
- Post-Marketing Surveillance and Vigilance
Marketing Authorization (MA)
Marketing Authorization involves a scientific review of evidence documents to ensure the quality, safety, and performance of medical devices and in-vitro diagnostics. Devices are classified into four risk categories: Class A (low risk), Class B, Class C, and Class D (high risk). In accordance with the applicable regulatory requirements, the type of assessment to be applied should be determined based on the classification of the device based on the current risk-based classification.
There are two primary routes for obtaining Marketing Authorization:
- Notification: Applicable for selected low-risk Class A devices, such as laboratory equipment and devices that are non-sterile, non-active, and lack measuring functions. This approach is based on the regulations and guidelines for notifying medical devices exempted from registration.
- Registration: Required for Class A devices that are active, sterile, or have measuring functions, and for devices in Classes B, C, and D.
Stages of Assessment
The document further describes in detail specific stages of assessment to be completed. As explained by the TMDA, the assessment process begins with pre-checking applications to confirm their completeness and proper organization. This step ensures that applications are correctly classified and include all necessary documents, facilitating an efficient scientific review.
Identifying missing information early prevents unnecessary delays and resource expenditure. Applicants should be fully aware of the Authority’s expectations at this stage, including target time frames, guidelines, requirements, templates, and checklists.
A clear understanding results in a more predictable process and benefits both parties when complete documents are submitted from the outset. The second stage involves a scientific review of the application dossier.
This stage includes two critical steps:
- First Assessment: The initial review conducted by a primary assessor.
- Second Assessment: A subsequent review by a secondary assessor to ensure no critical issues are overlooked.
Each application is assessed by two assessors based on a first-in, first-out concept, considering the assessors’ competency, expertise, and experience. These stages act as safeguards to maintain the quality of the report and adherence to GRevP.
During this stage, the need for a site inspection (Quality Audit) to verify the compliance of manufacturing sites is considered. Additional communication with laboratories may occur if sample analysis is required.
The dossier assessment stage concludes once all communications with the applicant have been finalized.
Upon completing the assessment and reaching final recommendations, legal and administrative procedures commence:
- Notification Applications: Submitted for approval by the DMD.
- Class A and B Applications: Submitted for approval by the Director General.
- Class C and D Applications: Presented before the technical committee for registration consideration.
Quality Audit
Another important aspect addressed in the guidance relates to quality audits. According to the document, Quality Audits aim to assess the compliance of manufacturing facilities for medical devices and in-vitro diagnostics with the minimum requirements of the latest ISO 13485 standards and other relevant standards applicable to specific devices.
Compliance verification is conducted through physical inspections or desk reviews. Quality Audit applications are submitted via the Regulatory Information Management System (RIMS) and processed as follows:
Pre-Checking
This initial step involves checking the completeness of submitted documents, which should include:
- A filled application form.
- The Site Master File (SMF).
- The Quality Manual.
Pre-Assessment
The application is reviewed to categorize the manufacturing facility, determining whether it qualifies for a desk review or requires a physical quality audit.
Assessment
For applications qualifying for a desk review, the assessment stage involves:
- First Assessment: Conducted by a primary assessor based on a first-in, first-out concept, taking into account the assessor’s competency, expertise, and experience.
- Second Assessment: A secondary review to ensure that no critical issues are overlooked and that GRevP are followed.
These dual assessments serve as safeguards to uphold the integrity and thoroughness of the review process.
Final recommendations from regulatory experts are communicated to the DMD through the Medical Devices and Diagnostics Laboratory (MMDL). If satisfied, the DMD submits the recommendations to the Director General for final approval. Upon approval, certificates of compliance are generated through RIMS and sent to the applicant.
Conclusion
In summary, the present guidance outlines the key aspects of managing assessment processes, marketing authorization, and quality audits for medical devices and in-vitro diagnostics.
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