MD-41 & MD-42 Licenses for Medical Devices in India – CDSCO Compliance Explained

1. Navigating MD 41 & 42 Licenses for Medical Devices in India With the increasing demand for healthcare products, the Indian government has implemented strict regulations to ensure the safety and quality of medical devices. This presentation will guide you through the essential information regarding MD 41 and MD 42 licenses, including the registration process, eligibility, and validity. www.medicaldeviceregistration.com

2. Understanding MD 41 & MD 42 Licenses MD 41: Application Form MD 42: Issued License This is the application form used to request the registration certificate for selling, stocking, exhibiting, or distributing medical devices and IVDs. It's the initial step in the licensing process. This is the actual license issued by the State Licensing Authority (SLA) after successful submission of Form MD 41 and a thorough inspection. It grants legal permission for wholesale distribution.

3. Why MD 41 & MD 42 Licenses are Crucial Regulatory Compliance Ensuring Public Safety Quality Control & Standards Ensures imported medical devices meet CDSCO standards, making it mandatory for all distributors to operate legally. Guarantees products are safe for use and comply with CDSCO guidelines, protecting consumers. Ensures rigorous scrutiny for high quality and efficacy, meeting both international and national standards.

4. Benefits of Obtaining MD 42 License Building Market Trust Business Expansion Obtaining this license builds trust in the market and boosts sales, assuring consumers of product safety and regulatory authorization. It opens opportunities for business expansion, allowing access to the large Indian healthcare market while complying with local laws. Legal Protection Ensures legal protection by operating within Indian laws, helping businesses avoid penalties, fines, and product confiscation.

5. Application Process for MD 42 License Fill Application Form MD 41 Submit Form MD 41 online or offline, depending on state-specific portals or by visiting the State FDA office. Prepare Documentation Attach all mandatory documents; omissions may lead to application rejection. Submit Application Fees Pay the government fee of Rs. 3000, which is subject to change based on updates. Audit Process A Drug Inspector will review premises or conduct document verification at the FDA office. Issue License Upon satisfactory review, the MD 42 license is issued by the State Licensing Authority.

6. Required Documents for MD 42 License Compliance Declaration Application Forms Premises Details Staff Qualifications Completed Form MD-41 and a cover letter stating business intent. Floor/site layout, rent agreement or property proof, and storage facility details (including refrigeration if needed). A declaration of regulatory compliance, along with other necessary documents like GST and Trade License. Employee qualifications, resume, academic certificates of competent technical staff, and affidavit of appointment.

7. Competent Technical Staff Requirements Registered Pharmacist A person holding a degree from a recognized University/Institution, who is a registered pharmacist. 1 Intermediate Examination 2 Or, a person who has passed the intermediate examination with one year of experience in dealing with the sale of medical devices. Supervisory Role 3 The candidate must be appointed to direct and supervise the sales activity of medical devices.

8. ELT Corporate: Your Partner in Compliance Hassle-Free Licensing ELT Corporate assists in obtaining MD 41 & MD 42 licenses by managing the entire process. Comprehensive Support This includes document preparation, application filing, regulatory compliance, and follow-ups with authorities. Expert Supervision We provide a fast, flawless, and hassle-free licensing experience under professional supervision for your medical device company.