Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B81: Product registration/approval 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

6. A person shall not sell, manufacture, import or export, distribute, provide as a grant or gift or offer for sale any medical device unless it is registered by the Authority.
13.-(1) An medical device in Class A, may be exempted from registration due to the low risk associated with their use as provided for in the Classification Rules for Medical devices in the First Schedule and their specific intended purpose as prescribed in the third column of the Second Schedule to these Regulations.
24. No person shall manufacture for sale, import, or supply any medical device unless- (a) the medical device is registered.
50.-(1) No person shall import any medical device unless it is registered by the Authority. 

Reference of the measure

Part III Regulations 6 and 13 (1 )
Part IV Regulation 24 (a)
Part V Regulation 50(1) 

Measure also domestic

Yes 

Products affected by the measure.

Description

Medical Devices 

Countries/Regions affected by the measure.