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.
The decision to introduce QMS requirements comes after discussions at the Drugs Technical Advisory Board (DTAB) meeting. During the meeting, it was observed that;
“The scope for conformance of Quality Management System for manufacturing of such medical devices is not included in the above said rules. Quality Management System is utmost important for manufacturing of medical devices to ensure that the product meets relevant standards & Essential principles applicable for medical devices and the firm shall adhere with the Quality Management System of Fifth schedule of Medical Device Rules, 2017.”
It was further clarified;
“So that the safety & performance of medical devices will be ensured, hence the undertaking stating that the manufacturing facility has complied the Quality Management System as prescribed in the Fifth schedule of Medical Device Rules, 2017 may be included in the said rules.”
Accordingly, it was proposed that to amend rule 19H and 19J of chapter IIIB of Medical Device Rules, 2017 to include the Quality Management System requirements for class A (non-sterile and non-measuring) medical device.
DTAB deliberated the matter and agreed for the proposed amendment under Medical Devices Rules, 2017.
