Navigating India’s stringent medical device regulatory landscape necessitates a comprehensive understanding of pivotal documents, including FORM MD-3, MD-5, MD-7, and MD-9. These forms play a critical role in obtaining licenses for manufacturing and selling medical devices, ensuring adherence to Central Drugs Standard Control Organization (CDSCO) regulations.
You can also check our service page on the CDSCO Manufacturing license for more details.
What is FORM MD-3?
FORM MD-3 serves as the gateway for manufacturers seeking licenses to produce, sell, or distribute Class A or Class B medical devices within India. These devices, categorized based on their risk levels, encompass low to moderate-risk products. This form acts as the initial step for manufacturers to appy for venturing into the licensing and commercialization of these specific categories of medical devices.
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What is FORM MD-5?
FORM MD-5 is the final approved license for manufacturing. It follows the submission of FORM MD-3 and represents CDSCO’s grant of a license to manufacture, sell, or distribute Class A or Class B medical devices after a meticulous review and approval of the submitted documents.
What is FORM MD-7?
On the other hand, FORM MD-7 holds significant importance in acquiring manufacturing licenses for Class C and Class D medical devices. These categories encompass moderate to high-risk and high-risk devices, respectively. Due to their potential impact on patient safety and health, the process of license application for these devices is notably regulated.
What is FORM MD-9?
FORM MD-9 is final license approved for manufacturing of Class C and D medical devices, following the submission of FORM MD-7. It signifies CDSCO’s issuance of a manufacturing license after stringent scrutiny and compliance verification for these higher-risk devices.
Key Highlights of the Application Process:
- Eligibility: FORM MD-3 is for Class A and Class B device manufacturers, while FORM MD-7 is designated for Class C and Class D devices.
- Submission and Documentation: Comprehensive documentation, including device master files, quality management systems, ownership details, and manufacturing declarations, is required as per CDSCO guidelines.
- Compliance and Review: Scrutiny of applications ensures adherence to regulatory norms. Any queries or deficiencies must be addressed promptly.
- Premises Audit: Higher-risk devices undergo thorough audits by notified body and CDSCO to assess conformity with standards.
- Evaluation and Issuance: Upon meeting prerequisites, the CDSCO issues FORM MD-5 (for MD-3) or the manufacturing license (FORM MD-9 for MD-7), allowing the manufacturing and sell of approved medical devices.
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Conclusion
FORM MD-3 and FORM MD-7 signify the initial stages in the approval process for manufacturing licenses for medical devices in India.
