Medical Devices

Medical Devices are critical for the effective treatment of human health-related issues. Patients undergoing any form of treatment should not be adversely affected by medical devices that are used during a treatment which could result in adverse impacts. Medical Devices are therefore regulated by governments through laws and controls. The Medical Devices Rules: 2017, have been notified by the Central Government (Government of India) and have been in effect since 2018. The rules are harmonized with international regulatory practices.

Medical Devices have a classification based on the Risk they may pose on the patient due to the device. The lowest risk devices are classified as A, then B, C, and the most severe risk devices as D. For risk categories A and B, CDSCO has recognized Quality Austria Central Asia as a Notified Body under the Medical Device Rules: 2017. Notified Bodies are nominated by the State Governments to conduct Audits on behalf of the State Licencing Authority, of a particular Medical Device manufacturer and to submit their report and based on the report, the State Government Licencing Authority would issue a certificate. For risk categories C and D, the Central Licencing Authority is responsible, and they do not nominate Notified Bodies to conduct the audit on their behalf. The Notified Bodies would audit the manufacturing covering the following

• • technical review of respective documents as prescribed
• • on-site audit of the manufacturer’s quality management system as laid in the fifth schedule of the Medical Device Rules:2017
• • establish conformity by examination and provision of objective evidence
• • to the essential principles laid down by the Central Government from time to time
• • establish design conformity by reviewing the design documents during
• • assessment of medical devices to ensure their quality, safety, and performance
• • QACA is recognized as a “Semi Regulator” or a Notified Body by CDSCO
• • We are approved via Notification related to MD-2 ie we can grant licenses for the Manufacturing, Sales, Storage, Distribution, and Exhibition of Medical Devices for Class A and Class B
• • QACA will grant a license as per Schedule 4(Plant Medical File ie MD-5) and Schedule 4(as per ISO 13485)
• • Non-measurable and Non-Sterile Devices, No Audit is required(Notified dated 14/10/2022); clients can directly register on the CDSCO Portal and they are granted Licenses.

Medical Device Classifications