- Your Strategic Partner For Regulatory Compliance
MD-9 refers to the Manufacturing License granted by the Central Licensing Authority (CLA) under the CDSCO (Central Drugs Standard Control Organization) to manufacturers after a successful application via Form MD-7. It grants legal authorization to manufacture and sell Class C or D medical devices in India.
Companies established in India who intend to manufacture and sell Class C or Class D medical devices require this license. Here’s a breakdown of the device classifications:
Class C: Moderate-Risk Devices
These are medical devices considered to have a moderate to high risk to patients. They require stricter regulations and controls compared to Class A and B devices. For Example:-
Class D: High-Risk Devices
These are medical devices considered to have the highest risk to patients. They require the most stringent regulations and controls to ensure safety and effectiveness. For Example:-
The process for acquiring an MD-9 Manufacturing License involves following stages:
The Form MD-9 license is valid indefinitely, subject to timely payment of a license retention fee every 5 years. Non-payment may lead to suspension or cancellation of the license.
Regulatory Expertise: They’re well-versed in the intricacies of the Medical Device Rules, 2017, ensuring your application adheres to all requirements.
Streamlined Process: They guide you through every step, from understanding eligibility to assembling the comprehensive documentation package.
Accurate Documentation: MDR consultants ensure your technical specifications, device master files, QMS documents, and other crucial documents are complete, accurate, and formatted according to CDSCO standards.
Effective Communication: They handle communication with the CDSCO on your behalf, addressing any concerns and ensuring a smooth review process.
Risk Management & QMS: They can help develop and implement robust Risk Management and Quality Management Systems (QMS) that meet regulatory standards, demonstrating your commitment to safety and quality.
Increased Success Rate: Their expertise helps you avoid common pitfalls and delays, significantly increasing your chances of obtaining the MD-9 license efficiently.
MDR consultants often offer additional services, such as:
Pre-market regulatory consulting to determine device classification and plan your compliance strategy, Site readiness for the Licencing audit/ final audit. MDR consultants perform stage wise internal audit to get prepare for the final stage of audit to be conducted by the CLA, Post-market surveillance support to monitor device performance and address safety concerns, Regulatory compliance training for your staff.
Don’t navigate the MD-9 process alone. Get a free quote from our experienced MDR consultants today and ensure a smoother journey to market for your medical devices!
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