Manufacturing Licenses for Class C & D Medical Devices (Forms MD-7, MD-9)

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.

Who Needs MD -9

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:-

·         Blood Bags

·         Catheters

·         Disposable Perfusion Sets

·         Ablation Devices

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:-

·         Aneurysm clip

·         Heart Valves

·         Cortical electrode

·         Cervical spine immobilization head ring

Benefits of Obtaining MD-9:

• Market Access: Enter the booming Indian medical device market.
• Legality & Credibility: Operate legally and gain trust with regulators and healthcare providers.
• Competitive Edge: Stand out and partner with distributors and hospitals.
• Operational Efficiency: Manufacture and sell Class C & D devices freely.
• Long-Term Stability: Enjoy a valid license with timely renewals.
• Bonus: Participate in government tenders and show commitment to patient safety.

Process to Obtain MD-9 License:

The process for acquiring an MD-9 Manufacturing License involves following stages:

• Application (Form MD-7): Submit an application electronically to the Central Licensing Authority through the CDSCO portal.
• Documentation: Include required documents like:
• Cover letter
• Plant master file and device master file
• Quality Management System (QMS) documentation as per regulations
• Performance evaluation report (for In Vitro Diagnostic Devices – IVDs)
• Company details (constitution, ownership/tenancy agreements)
• Valid Quality Certificate for the manufacturing site
• Valid Test License for testing and generating quality control data
• Signed undertaking stating compliance with QMS provisions
• Review & Inspection: CDSCO reviews the application and conduct an inspection of the manufacturing site.
• Approval: Upon successful review of the application, documentation, and potential inspection, the CLA grants the manufacturer a license to manufacture and sell Class C or Class D medical devices. This license is issued in the form of MD-9.

Validity:

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.

Important Tips:   

• Ensure the manufacturing site meets QMS requirements as per the Fifth Schedule of the Medical Device Rules, 2017.
• Prepare device master files and site master files according to the MDR 2017 format.
• Submit technical documents compliant with MDR 2017 to avoid delays.
• Generate quality control data based on a valid Test License for quicker approval.  

• Upon successful review of the application, documentation, and potential inspection, the SLA grants the manufacturer a license to manufacture and sell Class A or Class B medical devices. This license is issued in the form of MD-5.

Here's why an MDR consultant is your ideal partner:

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.

Beyond the MD-9 Application:

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.