Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B31: Labelling requirements 

Date when the measure came into force

03 July 2015 

Publication where the measure is specified

The Tanzania Food, Drugs and Cosmetics ACT, 2003 

Regulation where the measure is specified

Tanzania, Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015 

Country/Region applying the measure

Tanzania 

Coded list of objectives

A: Protection of human life and health 

Description of the measure

74.-(1) No person shall import or sell a medical device unless has a label that sets out the following information-
(a) the name of a medical device;
(b) the name and address of manufacturer;
(c) the identifier of a medical device, including the identifier of a medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(d) batch or lot number;
(e) if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to a medical device, such as size, net weight, length, volume or number of units;
(f) the words “Sterile” if the manufacturer intends to sale a medical device in a sterile condition;
(g) the words “for single use only” if the medical device is intended for that purpose;
(h) the expiry date of the medical device expressed in month and year;
(i) unless self-evident to the intended user, the medical conditions, purposes and uses for which the medical device is manufactured, sold or represented, including the performance specifications of the medical devices if those specifications are necessary for proper use;
(j) the directions for use; and
(k) any special storage conditions applicable to the medical devices.
(2) The information required pursuant to subregulation (1) of this Regulation shall be expressed in a legible, permanent and prominent manner, in terms that are easily understood by the intended user.
(3) Subject to sub-regulation (4), if a medical devices is intended to be sold to the general public, the information required by sub-regulation (1) shall -
(a) be set out on the outside of the package that contains the medical devices; and
(b) be visible under normal conditions of sale. (4) Where a package that contains a medical devices is too small to display all the information in accordance with sub-regulation (1) of this Regulation, the directions for use shall accompany the medical device but need not be set out on the outside of the package or be visible under normal conditions of sale.
(5) Notwithstanding with provision of sub regulation (4) the accompany information shall be provided in the package inset, manual, booklet, or any other means as the case will be.
75. The information required by regulation 74 shall be in either English or Kiswahili or both English and Kiswahili. 

Reference of the measure

Part VIII Regulations 74 and 75 

Measure also domestic

Yes 

Products affected by the measure.

Description

Medical devices 

Countries/Regions affected by the measure.