Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B31: Labelling requirements 

Date when the measure came into force

24 March 2014 

Publication where the measure is specified

Statutory Instruments 29 of 2014. 

Regulation where the measure is specified

The National Drug Policy and Authority (Registration) Regulations, 2014. 

Country/Region applying the measure

Uganda 

Coded list of objectives

A: Protection of human life and health 

Description of the measure

29 (1) The applicant shall submit with the application for registration of a surgical instrument, a label which shall have—
(a) the name of the surgical instrument;
(b) the name and address of the manufacturer of the surgical instrument;
(c) the identifier of the surgical instrument, including the identifier of any surgical instrument or appliance that is part of a system, test kit or group;
(d) where the contents of the package of the surgical instrument are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the surgical instrument, such as the size, net weight, length, volume or number of units;
(e) the word “Sterile”, if the manufacturer intends the device to be sold in a sterile condition;
(f) the expiry date of the surgical instrument, where applicable, to be determined by the manufacturer on the basis of the component of the surgical instrument, as the case may be, that has the shortest projected useful life;
(g) unless self-evident to the intended user, the medical conditions, purposes and uses for which the surgical instrument is manufactured, sold or represented, including the performance specifications of the surgical instrument, where those specifications are necessary for proper use;
(h) the directions for safe and effective use of the surgical instrument, unless directions are not required; and
(i) any special storage conditions applicable to the surgical instrument.
(2) The information required under subregulation (1) shall be provided in English, and shall be in a permanent and prominent manner, in terms that are easily understood by the intended user.
35 (2) Where the package that contains the surgical instrument or appliance is too small to display all the information required under regulation 29 on the outside of the package, the directions for the use of the surgical instrument or appliance shall accompany the surgical instrument or appliance. 

Reference of the measure

Part III Regulations 29 (1) & (2); Regulation 35 (2) 

Measure also domestic

Yes 

Products affected by the measure.

Description

Surgical instruments 

Countries/Regions affected by the measure.