Non-Tariff Barriers

NTM classification: B82: Testing requirement
Date when the measure came into force: 14 January 2013
Publication where the measure is specified: Official Gazette n° Special of 17/01/2013
Regulation where the measure is specified: Law No47/2012 Of 14/01/2013 Relating To The Regulation And Inspection Of Food And Pharmaceutical Products
Country/Region applying the measure: Rwanda
The rationale of the measure: To identify their effectiveness and potential adverse effects related to their use.
Coded list of objectives: X: For purposes n.e.s.
Description of the measure: Pharmaceutical products or medical devices whether manufactured in the country or imported must have undergone a thorough clinical trial to identify their effectiveness and potential adverse effects related to their use.
Reference of the measure: Art 30
Measure also domestic: No

Code	Product	Partial coverage	Partial coverage indication	Date in	Date out
PG: 24	Medicines for human use	No
PG: 26	Medical devices	No

Description: Pharmaceutical products and medical devices
pharmaceutical product: any substance capable of preventing, treating human or animal diseases and any other substance intended for administration to a human being or an animal in order to diagnose diseases, restore, correct or carry out modification of organic or mental functions. It also means products used in disinfecting premises in which food and drugs are manufactured, prepared or stored, cleaning hospitals, equipment and farm houses.

Medical device: any device used in the medical field for the purpose of diagnosis, testing, cure, surgery or health protection.

Inclusion/Exclusion	Country	Date in	Date out
Inclusion	Entire world

Reporting, Monitoring and Eliminating Mechanism