Regulatory Setup for Refurbished Medical Devices

PROBLEM STATEMENT

A Mumbai-based company sought to establish a process for importing and refurbishing medical devices such as CT Scans, MRIs, Ultrasound machines, and X-Ray equipment. These devices, sourced from international markets, needed to be reconditioned in India for resale while complying with Indian regulatory requirements. The challenge was to navigate the regulatory framework for refurbished medical devices under the Medical Device Rules, 2017, which mandate strict quality and safety standards.

Our Approach

Regulatory Assessment and Compliance:
D2R provided a comprehensive overview of Indian regulatory requirements for refurbished medical devices. This included
- Guidance on importing used medical equipment under customs regulations.
- Adherence to the Medical Device Rules, 2017, ensuring compliance with safety, quality, and performance standards.
Process Setup:
Prepared and submitted detailed documentation, including
- Assisted in setting up a reconditioning facility in India, including compliance with ISO 13485 for quality management systems.
- Designed workflows for refurbishing devices to meet original manufacturer specifications and safety requirements.
- Developed SOPs for disassembly, testing, and reassembly of devices.
Documentation and Certification:
- Prepared the necessary documentation for regulatory approval, including details of refurbishment processes, testing protocols, and quality assurance measures.
- Supported the company in obtaining regulatory certifications for the refurbished devices, ensuring compliance with safety standards for resale in the Indian market.
Market Entry Support:
- Advised on labeling and post-market surveillance requirements for refurbished devices.
- Ensured that the devices met Indian standards for radiation safety and performance testing.

Outcome

The company successfully established a compliant refurbishment process, enabling them to import, recondition, and sell medical devices such as CT Scans, MRIs, Ultrasound machines, and X-Ray equipment in India. This setup ensured adherence to Indian regulations while maintaining high standards of quality and safety, allowing the company to cater to the growing demand for affordable medical equipment.

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Regulatory Setup for Refurbished Medical Devices

PROBLEM STATEMENT

Our Approach

Outcome

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