Class A Exempt Devices Need Permit Before Being Marketed in Tanzania

October 26, 2010
Before marketing a Class A device in Tanzania, manufacturers, importers, wholesalers and retailers must ensure the exempt status is up-to-date and must be able to verify the quality, safety and performance of the device through product testing and evaluation, a draft guidance says. While Class A devices are exempt from the country’s registration process, they must be covered by a permit, which expires each June 30. The permits must be renewed before Sept. 30 to avoid a 25 percent penalty fee, according to the draft released by the Tanzania Food and Drug Administration.
International Medical Device Regulatory Monitor