TMDA stands for the Tanzania Medicines and Medical Devices Authority, the regulatory body responsible for the regulation, approval, and post-market surveillance of medical devices in Tanzania.
I. Overall Market Access Framework and Key Rules
2.1 Two Access Routes: Registration and Notification
Tanzania defines Marketing Authorization as either ‘Registration’ or ‘Notification’. The two are parallel lawful routes, but their scope of application is strictly distinguished.
| Route | Applicable Products | Approval Outcome | Validity Period |
|---|---|---|---|
| Registration | Class B, C, and D medical devices and IVDs; as well as Class A products with any of the following features: (1) active devices; (2) devices with a measuring function; (3) devices supplied in a sterile condition | Certificate of Registration, subject to conditions determined by TMDA | 5 years |
| Notification | Class A medical devices and IVDs that do not have any of the three features above | Approval Letter | 3 years |
2.2 Applicant Eligibility and the Local Responsible Person (LRP)
The applicant must be a resident of Tanzania and must have obtained a medical device distributor license issued by TMDA. If the applicant is a foreign company, it must appoint a Local Responsible Person (LRP, also known as an authorized representative or local agent): the LRP must be a legal entity registered in mainland Tanzania and authorized by TMDA to deal in medical devices. The letter of appointment must be submitted to TMDA as part of the marketing authorization process.
The statutory duties of the LRP include four items: (1) Monitoring devices on the market and immediately reporting to TMDA upon discovering serious deficiencies or other issues that may endanger public health; (2) Serving as the communication channel between the applicant and TMDA; (3) Handling recalls; (4) Providing technical support and services to users of registered devices.
2.3 Language Requirements
All applications and supporting documents must be submitted in Kiswahili or English. Registration dossiers may use either language, but labels and instructions for use must be in Kiswahili for devices intended for home use.
2.4 Grouping Rules for Applications
Each application may contain only one of the following four categories: a single device, one device Family, one device System, or one device Group. For IVDs, there are two additional categories: Test Kit and Cluster.
| Grouping Type | Criteria |
|---|---|
| Family | Same product owner; same risk class; common intended purpose; common design and manufacturing process; variations limited to a closed list of permitted variants |
| System | Same manufacturer; components used together to achieve a common intended purpose; mutually compatible when used as a system; marketed under a single system name, or the labeling/instructions for use/catalog of each component indicates that it is intended for use with that system |
| Group | Two or more devices; identified under a single proprietary name; assembled and supplied by the product owner in a single packaging unit; having a common intended purpose (e.g., first aid kits, dressing trays, surgical kits) |
| IVD Test Kit | Same manufacturer; components used together to complete a specific intended purpose; marketed under a single test kit name; compatible; does not include instruments such as analyzers |
Restriction on the System category: devices registered as a System may be used exclusively with that system. If a device is intended for use with multiple systems, it must be registered separately with each system, or registered on its own.
2.5 Sample Requirements
Samples are a mandatory component of the marketing authorization application and must be submitted after payment of fees; applications not accompanied by samples will not enter review.
- Single-use devices: 2 units in commercial packaging are required for both new applications and re-registration;
- Small reusable devices: same as single-use devices, 2 samples;
- Devices intended for general use by laypersons: 2 samples;
- Large devices, devices that form part of hospital infrastructure, and cardiac implants: physical samples may be replaced by label mock-ups plus scaled photographs taken from multiple angles covering 360 degrees.
During the review process, TMDA may request additional samples. Sample exemptions apply only in specific circumstances and require a case-by-case request.
II. Classification Rules
3.1 Four-Tier Risk Classification
Tanzania adopts a four-tier classification of Class A, B, C, and D, consistent with the GHTF/IMDRF system.
If the applicant and the conformity assessment body disagree on classification, either party may request a ruling from TMDA in writing within 30 days of the date of the dispute; such a ruling is final.
III. Registration Process and Timelines
4.1 Full Process and Key Time Points
| # | Stage | Description | Timeline |
|---|---|---|---|
| 1 | Submission | Electronic documents submitted online | – |
| 2 | Screening | Verification of completeness; incomplete applications receive queries and are returned for correction; products wrongly declared as notification will be rejected and returned | An invoice is issued within 1-2 working days after completeness is confirmed, requiring the applicant to pay the applicable fees |
| 3 | Payment | The system generates an invoice; payment is made against a control number | Invoiced after receipt of a complete application |
| 4 | Scheduling | Complete applications (including samples) enter the review queue; scheduling time depends on device complexity and assessor availability | Class A/B: no more than 10 working days; Class C/D: no more than 20 working days |
| 5 | Assessment | First-round review plus second-round review, verifying compliance with quality, safety, and performance requirements (a quality audit of the manufacturing facility is also included in the assessment process; this timeline does not include the on-site audit period) | Class A/B: 23 working days; Class C/D: 40 working days |
Note: For the notification route, the application is subject only to a preliminary review, with a processing time of 5 working days.
IV. Fee Schedule
5.1 Reference Fee Schedule
Source: Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021, for reference only
Imported medical devices (USD):
| Item | Fee (USD) |
|---|---|
| Class A | 500 |
| Class B | 2,500 |
| Class C | 2,500 |
| Class D | 2,500 |
Imported in vitro diagnostics (USD):
| Item | Fee (USD) |
|---|---|
| Major variation | 300 |
| Minor variation | 150 |
| Retention fee (registered devices) | 200 |
| Retention fee (notified devices) | 50 |
Registration fees (USD):
| Item | Fee (USD) |
|---|---|
| Class A (registrable, supplied sterile or active, and with a measuring function) | 300 |
| Class B | 1,000 |
| Class C | 1,500 |
| Class D | 2,000 |
| Major variation | 500 |
| Minor variation | 200 |
| Retention fee (registered devices) | 200 |
| Retention fee (notified devices) | 50 |
GMP on-site inspection and QA fees: Asia, USD 6,000
This article is prepared based on publicly available TMDA regulations and the 2021 Fees and Charges Regulations. Fees and processing requirements are provided for planning reference only; the current TMDA announcements, application system, and case-specific requirements shall prevail.