Standards for Medical Devices-A Reference Document
Guidance document for Medical Devices is neither a regulatory nor a legal document. This document has been framed on the basis of Medical Device Rules 2017 issued by Government of India. If there are any errors or omissions found in this guidance document, readers are advised to refer to original Medical Device Rules 2017. The information contained in this document should not be a substitute for Medical Device Rule 2017.
The efforts made by IPC for bringing out this manual indicating the standards for medical devices highlight the Government’s intention to ensure the quality of medical devices for minimizing the patient safety risks. This is an important step in contextualizing and formalizing the country’s commitment to ensuring the quality of health care system by improving the quality of medical devices.
The Indian Pharmacopoeia Commission (IPC), under the aegis of the Ministry of Health and Family Welfare, has taken initiative to compile and publish the standards for medical devices as a Guidance Document for the benefit of the general public, patients and healthcare professionals as well.
The primary objective and scope of this document is to provide necessary information to all the stakeholders of the country regarding the regulatory requirements, quality management systems and standards required to be followed for medical devices.
Keeping in view the broad objectives for ensuring the protection of the health & safety of patients, healthcare professionals and others, the Ministry of Health & Family Welfare, Government of India has released the Medical Device Rules, 2017, effective from 1st January 2018 for regulating Medical Devices being used in the country.
This document will also serve as a reference manual for the licensing authority in the matters relating to medical devices.