REQUIREMENTS FOR THE IMPORTATION, MARKETING AND DISTRIBUTION OF MEDICAL DEVICES –GA-FDD
The Government Analyst – Food and Drug Department (GA-FDD) is hereby reminding importers and distributors about the requirements for the import of medical devices, particularly in vitro diagnostic (IVDs) test kits and laboratory reagents.
These requirements are in accordance with the laws of Guyana Food and Drug Act Chapter 34:03 Part VI Section 32(2), the Food and Drug Regulations- Part VII Section 115(c) and those articulated in the GA-FDD Application Form for a Permit to Import Medical Devices.
Importers / Distributors must therefore fulfill the following on or before devices / kits are released for sale or use in our health care delivery system:
- Importers / Distributors must be registered with the GA-FDD as an Importer and obtain a Permit to Import medical devices (IVDs- Kits and laboratory reagents).
- An import license and Customs Entry must be submitted to the department for approval and release.
- Importers / Distributors must demonstrate that Medical Devices are manufactured according to the International Standard Organization (ISO) 13485:2016 Standard.
- Importers / Distributors must demonstrate to the department by way of a Free Sale Certificate (FSC) that the medical device (in vitro diagnostic test kits and laboratory reagent) is freely sold and used in the country of origin.
- The Importer / Distributor must demonstrate to the GA-FDD that the company or individual is in possession of a Manufacturer’s or Distributor’s authorization from the manufacturer or a distributor.
The GA-FDD has observed an increase in applicants and requests for the importation of medical devices (IVDs test kits and laboratory reagents) in response to the COVID-19 pandemic. The World Health Organization (WHO) however, has to date only approved the use of the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test method for the identification and laboratory confirmation of the COVID-19 diagnosis.
The Department will facilitate the importation of test kits that utilize the RT-PCR method from the eight countries which have been listed by the WHO to produce IVDs test kits and laboratory reagents for the COVID-19 diagnosis. Those countries are Australia, Brazil, Canada, People’s Republic of China, Russian Federation, Singapore, Republic of Korea, and the United States of America.
With regards to Rapid Diagnostic Tests (RDTs) that are either serological (blood –antibodies) or antigen-based (viral proteins), none has been approved or validated by the WHO as a result of several challenges associated with sensitivity and specificity. The GA-FDD will ONLY approve the use and facilitate the import of RDTs for COVID-19 diagnosis which have been approved and validated by the WHO or a serious Reference Authority.
The Department is therefore warning consumers, healthcare professionals, public and private health care providers of a growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19. The WHO, on 31st March, 2020, issued Medical Product Alert No 3/2020 on this issue. See full alert. https://www.who.int/news-room/detail/31-03-2020-medical-product-alert-n-3-2020. The GA-FDD wishes to also reiterates the need for importers and distributors to follow the respective guidelines and exercise caution to avoid undue issues or delays and to aid in the fight against this pandemic.