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MEDICINES CONTROL COUNCIL - mccza.com
Registration of Medical Devices and IVDs General Information MEDICINES CONTROL COUNCIL GENERAL INFORMATION MEDICAL DEVICES and IVDs This guideline is intended to provide recommendations to interested persons wishing to submit applications for the licensing of manufacturers, distributors and wholesalers, and registration of medical devices and IVDs. It represents the COUNCIL s current thinking on the safety, quality and performance of medical devices and IVDs. It is not intended as an exclusive approach. The COUNCIL reserves the right to request any additional information to establish the safety, quality and performance of a medical device or IVD in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used but these should be scientifically and technically justified. The COUNCIL is committed to ensure that all registered medical devices and IVDs will be of the required quality, safety and performance.
Registration of Medical Devices and IVDs General Information . MEDICINES CONTROL COUNCIL . GENERAL INFORMATION MEDICAL DEVICES and IVDs
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