The Drugs Controller General of India (DCGI) is looking to make changes to the Medical Devices Rules, 2017 to set standards for the quality of non-sterile and non-invasive medical devices. This would include products like thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs.
At present, there is an exemption for licensing to manufacture and import Class A medical devices (non-sterile products) in India. However, there is currently no requirement for these devices to conform to a quality management system under the existing rules.
This issue was discussed at a recent meeting of the Drugs Technical Advisory Board (DTAB), the top technical advisory body on drugs and medical devices in the country. The board noted that while the rules allow for the exemption of licensing for Class A medical devices, there is no provision for ensuring that the manufacturing process meets quality standards.
To address this, it has been proposed that a statement declaring compliance with the quality management system outlined in the Medical Devices Rules, 2017 be included in the regulations. This would help ensure that the safety and performance of medical devices are maintained.
Maintaining quality is crucial in the manufacturing of medical devices to ensure that the products meet the necessary standards. Adhering to the Quality Management System outlined in the rules is essential for ensuring the safety and effectiveness of medical devices.
In India, regulations like the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and the Medical Devices Rule, 2017 are in place to safeguard the well-being of patients by regulating drugs, medical devices, and cosmetics.
The medical devices sector in India is currently valued at around $11 billion, with projections suggesting it could reach $50 billion by 2030. To uphold safety standards, the drug regulator is also considering establishing qualification criteria for medical device testing officers and expanding the number of testing laboratories in the country.
