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.

Inclusion/Exclusion Country Date in Date out
Inclusion Entire world