Latest update March 21st, 2025 7:03 AM
Latest News
New standards implemented for the importation of medical devices
The Government Analyst Food and Drug Department (GA-FDD) has revised and implemented new requirements for the importation of blood pressure and glucose testing machines, ultrasound and other medical devices.
Marlan Cole
These new requirements are set out to ensure that all of the important devices are within the international benchmarks and standards.
For the first time, importers are now required to provide certification which demonstrate that their imported devices have been approved by the International Standards Organization (ISO) 13485 standard.
They must attain an original Free Sale Certificate from the regulatory body of the country where the medical device is manufactured; and the manufacturer of the devices has to obtain a Medical Devices Single Audit Programme (MDSAP) certificate.
Prior to this, the GA-FDD did little or conducted no enquiry regarding the specificity of the devices, such as where it was manufactured, whether it was approved by the country’s regulatory body, what standards were the devices manufactured to and whether the manufacturer was certified.
Before the implementation, the local importers only had to display whether they had the capacity to store the devices.
These new standards will come into effect in 2020, when importers make their applications, appealing for permission to import in the New Year.
The Food and Drug Act Cap 34”03 of 1971 and the Food and Drug Regulations of 1977, defined a medical device as “any instrument, apparatus, or contrivance, including components, parts and accessories thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal state of health or the symptoms thereof, in man or animals, or used or intended to be sued for the prevention of uterine conception.”
Director of the GA-FDD, Marlan Cole explained that the country’s legislation does not allow regulations of devices for personal use.
However, anything that is being imported for commercial use and the general public will be regulated and verified.
Recently, Cole graduated as a Doctor of Public Health, the highest award any University in the region could offer.
Similar Articles
THE BLUNT OF THE DAY
Sports
Features/Columnists
“One Guyana” is no less a national slogan than “Green Guyana”
Kaieteur News- The notion that “One Guyana” is a partisan slogan is pure poppycock. It is a desperate fiction... more
If Guyana’s President Ali is the “Zelensky of the Caribbean”, who is the Putin?
Antigua and Barbuda’s Ambassador to the US and the OAS, Ronald Sanders By Sir Ronald Sanders Kaieteur News- In the latest... more
Weekend Cartoon
