Medical Device Manufacturing License in India
At Medral Global, we specialize in providing expert services for obtaining a Medical Device Manufacturing License in India, ensuring your products comply with the stringent requirements set by the Central Drugs Standard Control Organization (CDSCO). Our comprehensive approach covers every step of the licensing process, making it easier for you to navigate the complexities of regulatory compliance.
We begin by thoroughly understanding the specific regulatory guidelines that apply to your medical devices, including documentation, classification, and testing requirements as outlined by the CDSCO.
Our experienced consultants work closely with you to develop a tailored strategy addressing all regulatory aspects. This includes preparing and submitting essential documentation such as the Device Master File (DMF) and Site Master File (SMF), which are critical for demonstrating compliance with CDSCO standards.
We also assist in implementing and maintaining a robust Quality Management System (QMS) aligned with CDSCO regulations, ensuring that all manufacturing processes are controlled and documented according to the highest quality standards.
Steps in CDSCO Licensing:
Identify the risk class of medical device: CDSCO categorizes devices based on potential risk (Class A, B, C, or D). All notified Class A, B, C, and D devices require a manufacturing license.
For Class A and B devices, applications are submitted via Form MD 3 along with required technical documents. After the audit process, the State Licensing Authority (SLA) issues the license in Form MD 5.
For Class C and D devices, applications are submitted via Form MD 7 with the required technical documents. After the audit process, the Central Licensing Authority (CLA) issues the license in Form MD 9.
License renewal is mandatory before the expiry date.
For newly developed medical devices, manufacturers must apply for a Test License using Form MD 12 and subsequently obtain the manufacturing license using Form MD 13.
Quality Management System (QMS): Your Path to CDSCO Compliance with Medral Global
A strong QMS is essential for securing your Medical Device Manufacturing License and ensuring ongoing success in the regulated medical device industry. At Medral Global, we assist you in developing and implementing a QMS fully aligned with CDSCO’s rigorous standards.
Our experts start with a detailed assessment of your existing processes, identifying gaps and opportunities for improvement. We then help establish effective procedures and create comprehensive CDSCO-compliant documentation—including Standard Operating Procedures (SOPs), quality manuals, and work instructions—covering all stages from design to production and post-market surveillance.
We recognize that a QMS is a dynamic system requiring continuous updates to meet evolving regulations and market demands. Medral Global offers ongoing support through regular audits, risk assessments, and staff training to keep your team informed of the latest CDSCO guidelines and industry best practices.
Partnering with Medral Global means gaining deep expertise in CDSCO standards and a commitment to building a culture of quality within your organization. Our tailored solutions help reduce regulatory risks and boost your product’s reputation by ensuring consistent safety and efficacy.
Risk Analysis
Effective risk analysis is vital in the medical device industry to ensure product safety and efficacy throughout the device lifecycle. Medral Global’s risk analysis services help you proactively identify, evaluate, and mitigate potential risks using industry-recognized methodologies such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).
Our consultants collaborate with your team to develop a comprehensive risk management plan that meets or exceeds CDSCO requirements. We provide detailed documentation and help implement control measures while monitoring their effectiveness over time.
Integrating risk analysis at every development and post-market phase ensures your devices maintain the highest safety standards, protecting patients and strengthening your market position.
Medical Device Testing
Medral Global guides you through the medical device testing process, ensuring compliance with CDSCO regulations. Although we do not conduct testing ourselves, we assist in selecting accredited labs, defining test protocols, and aligning test plans with regulatory requirements.
Our support helps you manage testing efficiently and effectively, smoothing the path toward CDSCO approval and market entry.
Clinical Evaluations and Repairs
Clinical evaluations are essential for verifying the safety and performance of medical devices. Medral Global provides guidance on clinical study design, data analysis, and regulatory submission. We also offer support in repairing devices to maintain compliance with CDSCO standards.
Device Classification
Correct device classification is critical for licensing. Medral Global helps you navigate the CDSCO classification system to ensure your product is properly categorized and meets all regulatory obligations.
Documents Required for Manufacturing License:
- Constitution details
- Site ownership details
- ISO 13485 certificate
- Device Master File (DMF)
- Product Master File (PMF)
- Test license certificate
- Quality Management System (QMS) documents
- Fee challan
- Legal forms
By obtaining a CDSCO Manufacturing License through Medral Global, you demonstrate your commitment to patient safety and gain access to India’s vast and growing medical device market with confidence.