A reference document named Standards for Medical Devices (“Draft Guideline”) has been published in the CDCSO website for maintaining the standards of medical devices. This guideline is not a regulatory or a legal document but a guideline which can act as a reference document
This draft guideline is aimed at improving current medical device standards which will assist the manufacturers, traders/distributors, importers, clinical establishments, healthcare professionals and general public. This guideline is applicable to persons who deal with or are involved in – Import of medical devices, Manufacture for sale or for distribution, Sale, stock, exhibit or offer for sale of medical devices in India, Healthcare Professionals, Policy makers/Government organizations, Medical devices Procurement persons or agencies/organizations, Private and public hospitals, Medical devices testing, Quality monitoring, Associations of Industry, professionals, Hospital and the general public
Feedback for the guidance document have been invited and the comments and suggestions can be sent to the email address mvpi.ipcindia@gmail.com.
