DCGI to bring non-invasive medical devices like thermometers, stethoscopes under quality control
New Delhi: The Drugs Technical Advisory Board (DTAB) has approved a proposal to amend Rules 19H and 19J of Chapter IIIB of the Medical Devices Rules, 2017. The amendment aims to include Quality Management System (QMS) requirements for Class A (non-sterile and non-measuring) medical devices.
With this, stricter quality standards for non-invasive medical devices such as thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs will be implemented.
Presently, there is no specific requirement for quality management systems (QMS) for Class A (non-sterile) medical devices, which include these products.
The Medical Devices Rules, 2017 provide exemption from licensing requirements to manufacture and import of the Class A (Non-Sterile and Non-Measuring) medical devices for marketing in the country. However, manufacturers and importers can still obtain a registration number by submitting the required information under sub-rule (2) of Rule 19H & sub-rule (2) of 19J of Medical Devices Rules, 2017 respectively.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.