Quality and regulation standards for positron emission tomography equipment and bone marrow cell separator as medical devices in India

Abstract

Introduction: Indian medical devices regulations have drastic changes since 2018. Few amendments have been incorporated in 2020. However, certain devices which are still not regulated and there are no quality checkpoints available for scrutiny from Central Drug Standard Control Organization, Delhi. This manuscript aims to provide quality checklist for two medical devices, positron emission tomography equipment, and bone marrow cell separator which are neither categorized nor regulated by the central drug standard control organization, Delhi. Methods: The quality checklist for the selected medical devices has been prepared by the survey based evaluation and quality tests have been identified by various methods available in the literature for checking risks associated with medical devices. Results and Discussion: Following quality checklist steps such as designing of primary checklist, quality assurance parameter evaluation for pet medication fabricating plant and equipment qualification criteria was identified with cross referencing and literature search. Conclusion: the new regulations would increase the accountability of the manufacturers and the importers to provide an assurance of safety to the customer. It needs to be incentivized by giving preference in public healthcare procurement instead of seeking USFDA and CE approvals. For the import of medical devices, the application should be reviewed based on risk analysis as suggested for these two devices. Further, local manufacturing of medical devices should be encouraged in India for reduced the cost of the medical devices.