Govt introduces new requirements for importation of medical devices

0
Digital spectrum analyzer and electronic devices

The Government Analyst Food and Drug Department (GA-FDD) wishes to inform the general public, particularly importers of medical devices of new importation requirements.

These requirements are in an effort to ensure that consumers are not exposed to substandard medical devices which may have negative impact when used in the healthcare delivery system. As customary, importers are required to present a valid business registration, complete a Permit to Import application form and pay the non-refundable fee.

The application form now includes the new requirements which are:

1. Importers must demonstrate that the medical devices being imported are manufactured according the International Standards Organisation (ISO) 13485 standard.
2. Importers must demonstrate that manufacturers of the medical devices intended to be imported are in possession of a Medical Devices Single Audit Program (MDSA) certificate.
3. Importers must furnish an original Free Sale Certificate issued by the regulatory authority of the country of origin where the medical device is manufactured. Such certificate can be valid for a period of no longer than five (5) years.

The Department has recently benefitted from a series of capacity building exercises related to medical devices. The most recent being the MDSAP forum which was hosted at the Head Quarters of the Pan- American Health Organisation (PAHO) in Washington DC from the 5th to 6th December,2019. At that Forum were Medical Devices regulators and auditors from the global community. Issues relating to devices regulation and facility auditing were ventilated. In addition, the GA-FDD in now part of the PAHO working group on medical devices.

The Food and Drug Act, Cap 34:03 of 1971, and the Food and Drug Regulations, 1977 define 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 used for the prevention of uterine conception.”

Importers are reminded that all permits previously issued expire at December 31, 2019. No consignment shall be allowed entry in the absence of a valid Permit. The Permit to Import Application form can be downloaded from ga-fdd.gy website. Importers are free to contact the Department for any additional information.