From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. Thus, medical device manufacturers will have to implement a QMS that meets the requirements of Schedule V of the IMDR 2017. It is mandatory for manufacturers to be compliant with these requirements for the successful registration of their Class C and D devices.

In India, medical device registration and regulations are governed by the Central Drugs Standard Control Organization (CDSCO), which issued the IMDR in 2017. As mentioned earlier, compliance with the IMDR Schedule V requirements is essential for medical device manufacturers who wish to sell their products in India. The requirements are based on the International Organization for Standardization (ISO) 13485:2016 standard for medical device QMS. Compliance with Schedule V is crucial for demonstrating that a manufacturer’s QMS is effective and meets the Regulatory norms.  Non-compliance with the IMDR Schedule V requirements can result in delays in the registration process, fines, and the withdrawal of a product from the market.

The following are some of the steps that medical device manufacturers can take to achieve compliance with the IMDR 2017:

  • Identify IMDR Requirements Based on Device Classification: The IMDR classifies medical devices by their intended use, duration of use, and other factors. Manufacturers should identify the classification of their device and ensure that they understand the requirements.
  • Develop and Implement a QMS that Meets the Requirements of Schedule V of the IMDR: This involves developing policies and procedures that cover all aspects of device design, development, manufacturing, and distribution. It is important that the QMS is tailored to the specific needs of the manufacturer and their device.
  • Develop Policies and Procedures that Cover All Aspects of Device Design, Development, Manufacturing, and Distribution: This includes policies for risk management, design controls, complaint handling, labeling, packaging, and sterilization. The policies and procedures should be regularly reviewed and updated, as and when necessary.Establish Effective Processes for Quality Control (QC), Risk Management, and Corrective and Preventive Actions (CAPAs): This involves implementing processes to ensure that devices are manufactured in accordance with the QMS and Regulatory requirements, potential risks are identified and managed, and CAPAs are taken, whenever required.
  • Conduct Regular Internal Audits to Ensure that the QMS Remains Effective and Compliant: Internal audits provide manufacturers with an opportunity to identify areas for improvement and ensure that CAPAs are taken to address any non-conformities in the system.
  • Consider External Audits from Third-party Organizations to Identify Areas for Improvement and Ensure Ongoing Compliance with the IMDR 2017: External audits can provide manufacturers with a fresh perspective on the QMS and help them identify areas that need to be improved. External audits can also provide valuable feedback on compliance with the Regulatory requirements and ensure ongoing compliance with the IMDR.

In conclusion, if you are a Class C or D medical device manufacturer looking to sell your product(s) in India, it is important to follow the above steps to ensure compliance with the IMDR 2017 requirements. Start implementing a compliant QMS today! Book a meeting with us to know more about how to implement the IMDR at your organization and achieve compliance with our expert consultation services. Stay informed! Stay compliant!



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