GN 315 Section 6: No Unregistered Medical Device May Be Marketed in Tanzania

1. Key takeaways

The pivot of the Tanzanian device regime is a single sentence in Section 6 of GN 315: no person shall sell, manufacture, import, export, distribute, provide as a grant or gift, or offer for sale any medical device unless that device has been registered by TMDA. Everything else in the regime — classification, dossiers, timelines, fees — exists to serve this prohibition and the narrow exceptions carved out of it.

The reach of this sentence is broader than comparable provisions in most markets: it locks down six actions at once (sell / manufacture / import / export / distribute / provide as a grant or gift / offer for sale), and it leaves no exception for devices that are unregistered in Tanzania but already marketed in other countries. Read together with Section 76 (offences) and Section 77 (penalties under the parent Act), dealing in an unregistered device is a statutory offence, not a minor administrative defect.

GN 315 comprises 78 sections plus five schedules: the First Schedule (classification rules), the Second Schedule (list of notifiable devices), the Third Schedule (application forms of various kinds), the Fifth Schedule (import permit formats) and others. The schedules are not decorative attachments; several of them — especially the First and Second Schedules — directly decide whether a given product may enter through notification or must go through full registration.

2. Legal basis

3. Expert insights

Insight 1: Among the actions listed in Section 6, “offer for sale” is the easiest to overlook.

This means that trade fair participation, catalogue quotations and e-commerce listings can all fall within an offer for sale. GRZAN has encountered multiple cases in which companies believed that exhibiting without concluding a sale was harmless, yet the labels on exhibit items and the quotation sheets already constituted an offer. The Tanzanian provision on unregistered devices is drafted strictly and contains no wording that exempts unconcluded transactions. Marketing teams and regulatory teams must therefore share one calendar: no public commercial exposure of a device before registration or notification approval is in hand.

Insight 2: Section 24 sets three cumulative thresholds for manufacturing, importing or supplying, and all three must be met.

Section 24 provides that no person shall manufacture, import or supply any device for sale unless: (a) the device is registered; (b) the person holds a valid premises licence issued by TMDA; and (c) the manufacturing, sale and supply activities comply with the conditions of the licence. The three conditions are cumulative — a device with a certificate but a company without a premises licence is equally unlawful. This is the statutory basis for running product compliance and entity compliance as two parallel tracks that must both close before commercial activity starts.

Insight 3: Section 13 is the only statutory exit from Section 6, and it opens only for Class A.

Section 13(1): Class A devices may be exempted from registration by reason of their low risk in use, with the exemption grounded in the classification rules of the First Schedule and the specific intended purposes listed in column three of the Second Schedule. Section 13(2): where the intended purpose to be declared differs from that stated in the Second Schedule, the device remains subject to registration. In other words, the exemption is not granted automatically by class; it is assessed item by item against class plus intended purpose. A wording change in the intended use statement can flip a device from exempt to registrable.

Insight 4: Section 25 adds three absolute prohibitions that operate independently of registration status.

Section 25 prohibits manufacturing, importing, selling, supplying or arranging the manufacture of any adulterated device, counterfeit device or unwholesome device. These three categories remain prohibited even if the device holds a certificate — Section 25 offers no exemption on the ground of holding a registration. This is why compliance review cannot stop at the certificate check; quality and supply-chain controls must also keep adulteration, counterfeiting and unwholesome conditions out of the Tanzanian supply chain.

Insight 5: The penalties are not in the regulations but in the parent Act.

Section 76 states only that any person who contravenes or fails to comply with these Regulations, or who directly or indirectly aids another person to do anything prohibited by these Regulations, commits an offence; Section 77 states that a person convicted under these Regulations is liable to the penalties provided by the parent Act. Specific amounts must be traced back to Cap. 219. GRZAN notes that the figure of a maximum fine of one billion Tanzanian shillings circulating online has not been verified against any official source; treat it as a practical estimate only and do not include it in external documents pending verification.

4. Practical recommendations

1. Bring “offer for sale” into the compliance review of all marketing activities. Before the registration certificate or notification approval is obtained, exhibition materials, product pages on the corporate website and distributor quotations must either carry the statement that marketing authorization has not yet been obtained in Tanzania or stay offline.
2. Plan the product line and entity qualifications in parallel. Registration (product) and premises licensing (entity) are two independent approval tracks; the submission times should be staggered deliberately, but the completion times must be met simultaneously.
3. Never presume a Class A exemption. Compare the intended purpose wording against column three of the Second Schedule item by item; where the wording differs, prepare for registration.
4. Donations and free samples are not exemptions. Section 51 requires donated devices to comply with these Regulations, and Section 52 imposes separate marking and quantity limits on free samples (see article 34 of this series).

5. Verification checklist

• □ The single marketing route for the target device in Tanzania (registration or notification) has been confirmed, with no exception for placing an unregistered device on the market.
• □ All marketing materials have been screened for conduct constituting an “offer for sale”.
• □ The timetables for product registration and premises licensing have been synchronized.
• □ For Class A devices, the intended purpose wording in column three of the Second Schedule has been compared verbatim.
• □ The device has been confirmed not to fall within the three absolutely prohibited categories under Section 25.

Regulatory information verified as of 29 October 2026. All provisions cited in this article were checked against the texts officially published by TMDA (GN. No. 315 and Cap. 219); the content is re-reviewed whenever the regulations are updated.

• Local resources in Tanzania: GRZAN can coordinate licensed local responsible persons (LRP) and distributor resources covering online submission, sample delivery, quality audit support and port clearance.
• Service capabilities: classification determination, route selection between registration and notification, technical documentation (CSDT/STED) preparation and localization, GMDN coding 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.