Prepared by: Marlan Cole- Director Food and Drug Department (GA-FDD)
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Activity/Event:MEDICAL DEVICES SINGLE AUDIT PROGRAM (MDSAP) – FORUM Pan- American Health Organization (PAHO) 525 Twenty – Third Street, N, M, Washington, D.C. 20037, United States of America Location: Room C Washington D.C.
Dates:05-06 December 2019
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Participants: MDSAP Regulatory Authorities (RAs), Guest Regulatory Authorities and Auditing Organizations(AOs)
Objectives: 1. To formally invite to the Forum regulatory authorities that may be interested in being Affiliate members of MDSAP.
2. To discuss and present an overview of Affiliate Membership, MDSAP’s overview, MDSAP audit model, inclusive of other presentations from participating MDSAP Regulatory Authorities and Auditing Organizations.
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Justification 1. Medical devices registration is currently not done by the GAFDD, neither is specifically paid attention to by the GA-FDD. This situation is currently putting consumers at risk when using medical devices in Guyana.
2. The GA-FDD is in ungent need of building capacity and outlining startegy to effectively monitor the import of medical devices into Guyana.
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Recommendations/follow-up:
– The GA-FDD should urgently establish measures for the registration of medical devices, such measures should be inclusive of but not limited to ensuring medical devices are manufactured according to the ISO 13485 Standard.
– Before the registration of a medical device the Government Analyst –Food and Drug Department (GA-FDD) should request a certificate of Free Sale from the regulatory authority of the country of origin. Such a certificate should be renewed every (5) years.
– Suppliers of Medical Devices should be able to demonstrate that the manufacturers of those devices are in position of a certificate from the medical device Audit Program (MDSAP).
– The application Form used by the GA-FDD to issue an annual Import Permit to Importers of medical devices must be adjusted to request ISO 13485 product certification, Free Sale certificate request and MDSAP manufactures certification.
– The GA-FDD should also urgently identify a Focal Point on medical devices and an alternate Focal Point to join the Pan-American Health Organization (PAHO) to join the regional working group on medical devices. This will ensure equitable access to by Guyana to safe and effective medical devices and help to further strengthen the capacity of the GA-FDD to ensure substandard medical devices are not imported into Guyana.
– Classes or categories of medical devices monitored / registered by the GA-FDD must be ungently ratified and / or be determined.
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