New Delhi: The Drugs Controller General of India (DCGI) is planning to amend the Medical Devices Rules, 2017 to include a provision for quality requirement for non-sterile and non-invasive medical devices such as thermometers, stethoscopes, elastic bandages, and non-electrical wheelchairs.

Currently, there is a provision for licence exemption to manufacture and import Class A medical devices (non-sterile products) for marketing in the country and conformance to quality management system for manufacturing of such medical devices is not included in the existing rules.

The matter was discussed in a meeting of the Drugs Technical Advisory Board (DTAB), the country’s top technical advisory body on drugs and medical devices, held last month.

The board, which is a part of the Central Drugs Standard Control Organization (CDSCO), opined that a relevant clause under Medical Devices Rules, 2017 specifies the provisions for exemption of licence to manufacture and import Class A (non-sterile and non-measuring) medical devices for marketing in the country.

“It is observed that the scope for conformance of quality management system for manufacturing of such medical devices is not included in the above said rules,” the minutes of the DTAB meeting, reviewed by Mint, showed.

Therefore, it has been decided that a provision of undertaking stating that the manufacturing facility has complied with the quality management system, as specified in the Medical Devices Rules, 2017, will be incorporated in the existing rules.

Class A medical device is a low-risk device that has minimal or no invasiveness. These include measuring as well as non-measuring devices such as thermometers, stethoscope, elastic bandages, and non-electrical wheelchairs.

Queries sent to the health ministry spokesperson remained unanswered till press time.

Maintaining quality 

Quality management system is important for manufacturing of medical devices to ensure that the product meets relevant standards. Essential principles are applicable for medical devices and the firm shall adhere with the Quality Management System of Fifth schedule of Medical Devices Rules, 2017.

“So that the safety and performance of medical devices will be ensured, hence the undertaking stating that the manufacturing facility has complied with the Quality Management System as prescribed in the Fifth Schedule of Medical Devices Rules, 2017 may be included in the said rules,” the minutes said.

In India, the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Medical Devices Rule, 2017 ensure the safety, rights and well-being of the patients by regulating the drugs, medical device and cosmetics.

Currently, the market size of India’s medical devices sector is approximately $11 billion, which is expected to grow to $50 billion by 2030.

Earlier, Mint reported that the drug regulator is planning to frame the required qualification criteria for medical device testing officers and increase the number of medical device testing laboratories in the country to ensure that safety parameters are adhered to.