A reference document named Standards for Medical Devices (“Draft Guideline”) has been released by Indian Pharmacopoeia Commission (“IPC”) 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. It is released in the interest of safety, quality and performance of medical devices under the Medical Devices Rules, 2017 and is an important reference manual for industries which are related to medical devices and its standards which will improve the functioning of the same.
Feedback for the guidance document have been invited and the comments and suggestions can be sent to the email address mvpi.ipcindia@gmail.com.
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.
Key highlights:
This reference document contains the following information:
- Pictorial guidelines for process for Registration of Medical Devices in India have been depicted,
- A detailed list of applications forms required to apply for Medical Device approval,
- A list of documents required with the application for grant of licence to manufacture or import of Medical Device,
- A detailed list of Fees and Charges for Medical devices
Source: Central Drugs Standard Control Organization
