Local Responsible Person Appointment and Duties in Tanzania

1. Key takeaways

Tanzania imposes a mandatory Local Responsible Person (LRP) system on foreign manufacturers. Three rules in GN 315 form the skeleton:

• Regulation 8(4): an applicant who is not a resident of Tanzania shall appoint a local responsible person.
• Regulation 8(5): the applicant must submit the original certificate of power of attorney, a certified copy of a formal agreement, or any other official document of authorization, as proof of the LRP appointment.
• Regulation 9: the four statutory duties of the LRP.

Part I §2.2 of the 2024 Compendium of Guidelines makes the eligibility conditions more specific:

• The applicant shall be a resident of Tanzania and must be licensed by TMDA as a medical device dealer;
• Where the applicant is not a resident of Tanzania, an LRP must be appointed (also referred to as an Authorized Representative or Local Agent), and the LRP must be a company incorporated in Tanzania and authorized by TMDA to deal in medical devices.

Together, these provisions close the door on casual appointments: an LRP is not merely a mailing address or a courier contact, but a regulated entity with statutory duties and direct exposure to TMDA. Choosing the wrong LRP, or documenting the appointment imperfectly, can invalidate an otherwise complete submission.

2. Legal basis

3. Expert insights

Insight 1: Of the LRP’s four statutory duties, the first carries the word immediately.

Regulation 9 provides that the LRP shall: (a) monitor devices on the market and immediately notify TMDA upon discovering any problem with a registered device that may endanger public health; (b) facilitate communication between the applicant and TMDA on matters relating to the device; (c) handle device recalls; (d) provide technical support and services to users of registered devices.

The word immediately in item (a) carries no number of days, and it forms a separate formulation from the 24-hour/14-day timelines in regulation 42; as a practical estimate, immediate should be understood as no later than the strictest timeline in regulation 42. The LRP agreement should translate this duty into operational steps, with defined escalation channels to the manufacturer.

Insight 2: The LRP must be a company, not an individual, and must already hold TMDA authorization to deal in devices.

§2.2: the LRP must be a company incorporated in Tanzania and authorized by TMDA to deal in medical devices. This excludes individuals, and entities holding only an ordinary business licence without TMDA device-dealing authorization. GRZAN treats TMDA device-dealing authorization as the first verification item when selecting an LRP, before commercial terms are even discussed.

Insight 3: The applicant itself bears six responsibilities that do not overlap with the LRP’s duties.

§2.2.1 provides that the applicant is the legal representative entity of the device in the Tanzanian market, and its responsibilities are: a) providing true and complete scientific documentation; b) ensuring all supplementary data are submitted by the deadlines; c) where marketing authorization is granted: (i) ensuring continued conformity with the requirements for remaining in the registered device and IVD lists; (ii) submitting any changes to TMDA in accordance with the change guidelines; (iii) renewing the registration every 5 years; (iv) conducting market surveillance activities after the product obtains marketing authorization. The closing sentence of §2.2 states that where the applicant is a resident of Tanzania, it bears the duties listed in §2.2.2.

Insight 4: Part IV §3.1.2 adds a letter of no objection from the manufacturer for notification applications.

Where an imported product is submitted for notification by a local applicant, a formal letter from the manufacturer must be attached as proof that it has no objection to the listing of its product in Tanzania. The letter must be on company letterhead and signed, stamped and dated by the applicant or the manufacturer (applicable to local applicants). This is a document the foreign manufacturer must also issue under the notification route, and it cannot be replaced by the LRP authorization alone.

Insight 5: The authorization document must be an original.

Of the three types of proof listed in regulation 8(5), the first is an original certificate of power of attorney. This means an electronic scan may not be accepted, and a paper original must be prepared and sent internationally. GRZAN recommends confirming with the LRP the currently accepted form (original by courier or certified copy) before submission, to avoid a last-minute documentation gap.

4. Practical recommendations

1. Make the LRP’s TMDA device-dealing authorization the first verification item in selection, checking its authorization status and business scope.
2. Prepare the original power of attorney and allow time for international courier; prepare a certified copy of a formal agreement as backup in parallel.
3. Map the four duties of regulation 9 item by item in the LRP agreement, especially recall handling authority and technical support responsibilities, to avoid responsibility gaps.
4. Under the notification route, add the manufacturer’s letter of no objection: letterhead, signature, stamp and date — all four elements present.
5. Establish a direct vigilance information channel with the LRP, so that the immediate notification duty of regulation 9(a) is executable in practice.

5. Verification checklist

• □ Applicant confirmed as non-resident of Tanzania — an LRP must be appointed (regulation 8(4)).
• □ LRP is a company incorporated in Tanzania and authorized by TMDA to deal in devices.
• □ Original power of attorney obtained (regulation 8(5)).
• □ LRP agreement covers the four duties of regulation 9 (monitoring and reporting/communication/recall/technical support).
• □ Under the notification route, the manufacturer’s letter of no objection obtained (letterhead, signature, stamp, date).
• □ Direct vigilance information channel established to satisfy the immediate notification duty of regulation 9(a).

Regulatory information verified as of 29 October 2026. All provisions cited in this document were checked against the official published texts of TMDA (GN. No. 315, regulations 8 and 9; the June 2024 Compendium of Guidelines, Part I §2.2, §2.2.1, §2.2.2; Part IV §3.1.2), and will be re-checked when the regulations are updated.

• Tanzania local resources: licensed Local Responsible Person (LRP) and distributor resources can be coordinated to cover online submission, sample delivery, quality audit cooperation and port clearance.
• Service capabilities: classification determination, registration and notification pathway selection, technical documentation (CSDT/STED) preparation and localization, GMDN and grouping strategy, clinical evidence organization, software and AI device submissions, change management, vigilance and PMS reporting, annual retention fees and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.