This article continues from Part 1 of the Tanzania TMDA medical device market access guide, further covering labeling and instructions for use, STED registration dossiers, renewal and change management, and the special requirements for software as a medical device and borderline products.
6. Labeling and Instructions for Use Requirements
6.1 General Requirements
- Devices that are not appropriately labeled must not be placed on the market; devices without an appropriate label must not be used on others, including in investigative testing.
- The label of a registered device must bear the TMDA registration number.
- Labels must not contain any statement that expressly or implicitly suggests that the placing on the market or use of the product has been promoted or endorsed by TMDA, the Ministry of Health, or any of its affiliated bodies.
- Labels must be clear, durable, and conspicuous.
- The medium, format, content, legibility, and placement of the label must be appropriate to the device, its intended use, and the knowledge level of the intended users; the wording of the instructions for use must be readily understandable to the intended users and should be supplemented with illustrations where necessary.
- Devices for home use must be supplied with paper labels and instructions for use.
- Residual risks identified in the risk analysis must be reflected on the label in the form of warnings.
- Where a component is too small to accommodate all the information, it must at least include: the name, batch number, expiry date, contents, and storage conditions.
- Where a product requires an accompanying instrument, the above requirements apply equally to the instrument; the instrument must be clearly labeled as either new or reprocessed.
6.2 Label Placement
Information should, wherever possible, be placed directly on the device itself, on the individual primary packaging, or on the primary multi-component packaging; where this is not feasible, it may be placed in the accompanying instructions for use, manual, or an insert within the package. The registration number, the manufacturer and applicant information, the distributor information, and the QR code must be placed in a location accessible to the customer at the point of sale. Where multiple devices are packed together because individual packaging is impractical, the label may be provided as a single explanatory insert; where the same user or the same location receives multiple devices, only one label may be supplied, provided that additional copies are furnished as required.
6.3 Language
Labels and instructions for use should be in English and/or Swahili.
1. Medical devices for home use must be in Swahili;
2. Information that needs to be translated into Swahili should be placed alongside the English version; the placement of the translation may also be determined by a risk assessment, which must be submitted at the time of registration.
6.4 Labeling and Instructions for Use of IVDs
In addition to the general elements, IVD labels must indicate “For in vitro diagnostic use” or an equivalent symbol; the batch number/serial number (a control number may be used instead for accessories, and a version number for software); the expiry date (the year of manufacture where the instrument has no expiry date); net contents; sterility status and sterilization method; single-use indication; and designations for use only in performance evaluation before placement on the market, for non-clinical research/teaching/testing, or for demonstration purposes only (some of these may be affixed by the LTR of the importing country, the importer, or the distributor). Reagents and items supplied separately within a kit must each comply with the labeling requirements.
6.5 Electronic Instructions for Use (e-IFU)
For devices intended for professional use, paper instructions for use are recommended, but an electronic format is permitted provided the following conditions are met:
- The manufacturer must conduct and document a risk assessment on the implementation of electronic instructions for use, and the documentation must be retained.
- The manufacturer must establish procedures for the creation and revision of electronic documents.
- The e-IFU applies only to devices intended for professional users.
- Users must always be able to obtain a paper version free of charge and without unjustified delay, or within the time limit specified in the risk assessment.
- Where the information can be downloaded from the internet, the website address must be clearly printed on the physical label and presented in a way that highlights its purpose; the manufacturer/authorized representative must ensure that the electronic label is consistent with the paper instructions for use approved at registration.
- Devices for home use must be provided with paper instructions for use; an electronic version is optional.
7. Registration Dossier Requirements
7.1 General Device Information (Applicable to All Classes)
Regardless of class, the following basic information must be submitted: device name (generic and brand names); description (a summary of design, characteristics, and performance, including packaging information); GMDN category (if not classified under GMDN, the alternative coding system used must be explained); intended use and indications (including the target patient population, therapeutic or diagnostic function, setting of use, and single or multiple use); summary of the instructions for use (procedures, methods, frequency, duration, dosage, and preparation required for safe use); contraindications; warnings; precautions; adverse reactions; alternatives; storage conditions (based on stability studies); and the recommended shelf life.
7.2 Summary Technical Documentation (STED) Body
The required technical documentation must be complete in structure and include: device description and characteristics, conformity with Essential Performance and Safety Requirements (EPSP), materials, device specifications, verification and validation, shelf life, biocompatibility, clinical evidence, risk management, manufacturing information, labeling, and more.
Note: IVDs intended for the detection of diseases of important public health concern such as HIV, malaria, hepatitis, syphilis, and tuberculosis must undergo performance evaluation within Tanzania using samples from the Tanzanian population, submitted in accordance with the Guidelines for Clinical Performance of In Vitro Diagnostic Devices (TMDA/DMD/MDA/G/006).
7.3 Documentation Requirements for the Notification Route
The notification route requires fewer documents than registration, but the following must still be submitted: the LTR appointment letter (for foreign applicants) or a letter of no objection from the manufacturer for local applicants (on company letterhead, signed, stamped, and dated); product details (intended use, intended users, target population, a description of the commercial packaging of the accompanying products and the number of units); clear photographs of each face of the commercial packaging; mock-ups of the primary and secondary packaging labels; instructions for use/user manual/package insert; an ISO 13485 certificate or equivalent issued by an accredited conformity assessment body (CAB); a Declaration of Conformity (DoC) signed and stamped by the manufacturer; device specifications and a list of standards met; samples; instructions for use; and more.
8. Renewal of Registration and Change Management
8.1 Validity Period
A registration is valid for 5 years, and a notification approval is valid for 3 years, unless suspended or revoked by TMDA or voluntarily terminated by the registration holder. The validity is subject to three conditions: payment of the annual retention fee, and submission of post-market surveillance reports and adverse reaction reports.
8.2 Renewal Applications
A renewal application must be submitted at least 90 days before the existing registration expires, together with five sets of documents:
(1) A summary of all changes to the device since registration – both approved changes and changes still under review must be reported;
(2) Device specifications and certificates of batch analysis;
(3) Product information, including label artwork or mock-ups and instructions for use/user manual;
(4) Post-market surveillance reports;
(5) Two samples of commercial packaging from the same batch.
8.3 Suspension, Revocation, and Termination
TMDA may suspend or revoke a registration after stating its reasons in writing, or modify the conditions of the marketing authorization. Where the registration holder voluntarily terminates the registration, TMDA must be notified in writing with reasons at least 60 days in advance.
9. Special Devices
9.1 Software as a Medical Device (Part X)
The scope of application includes embedded software (ultrasound imaging software, pulse delivery software in pacemakers/ICDs), standalone software (X-ray image processing and diagnostic software running on general-purpose workstations), mobile applications (remote monitoring of vital signs), and web-based software (browser access, uploading patient images for diagnostic purposes).
The requirements cover: pre-market registration requirements (EPSP, labeling, software versioning and traceability, software verification and validation, clinical evidence, risk management, and cybersecurity supporting documentation); change notification; cybersecurity; and artificial intelligence medical devices (AI-MD). The compilation requires manufacturers to establish mechanisms covering the full lifecycle for requirements management, risk assessment, software verification and validation, change management, and traceability, to be used in conjunction with the national cybersecurity policies and guidelines issued by Tanzania’s e-Government Agency.
For standalone software, particular attention must be given to: software version naming and traceability, a complete declaration in the labeling of the operating environment (hardware configuration and operating system), and the completeness of the cybersecurity supporting documentation.
9.2 Borderline Products (Part XI)
Borderline products are products whose classification as a medical device, a medicinal product, or a cosmetic is difficult to determine at first assessment. The method of determination is not based on the manufacturer’s claim, but on the principal mode of action: if a product acts mainly through pharmacological, immunological, or metabolic means, it is not a medical device; if it acts mainly through physical or other means, with pharmacological, immunological, or metabolic action serving only an ancillary role, it may be a medical device.
Devices containing medicinal substances, devices containing materials of biological origin, disinfectants and device disinfection products, and drug-device combination products are all common areas of borderline classification; it is advisable to prepare documentation substantiating the mode of action at the project initiation stage.
This article is compiled on the basis of publicly available TMDA regulations. For specific products, the labeling, technical documentation, performance evaluation, and change requirements are subject to TMDA’s current provisions and case-by-case review opinions.