Services
Manufacturing Licenses
Form MD-5 (Class A & B Medical Devices)
This license is required for the manufacturing of Class A (low risk) and Class B (low-to-moderate risk) medical devices in India. Our team ensures that all necessary documentation, including quality certifications, is in place to comply with the Medical Device Rules, 2017. We guide you through each step, from preparing your application to securing approval from the Central Drugs Standard Control Organization (CDSCO).
Form MD-9 (Class C & D Medical Devices)
For manufacturers of Class C (moderate-to-high risk) and Class D (high-risk) medical devices, a more rigorous process is required. We handle the complex paperwork, including detailed technical dossiers and clinical trial results, ensuring that your devices meet Indian standards. Our experts streamline the submission and approval process, reducing delays and facilitating quicker market access.
Loan Licenses
Form MD-6 (Class A & B Medical Devices)
A Loan License allows businesses to manufacture medical devices using an existing licensed manufacturer’s facility. This is ideal for companies looking to enter the market without setting up their own manufacturing plant. We help you secure a Form MD-6 Loan License for Class A and B medical devices, ensuring compliance with all applicable regulations and standards.
Form MD-10 (Class C & D Medical Devices)
Similar to Form MD-6, a Form MD-10 Loan License allows you to use another manufacturer’s facilities to produce Class C and D medical devices. The process involves more stringent checks and documentation due to the higher risk classification of these devices. Our experts manage every step of the approval process to help you avoid delays and ensure seamless compliance with regulatory requirements.
Sterilization Loan Licenses
Sterilization is critical to ensuring that medical devices meet health and safety standards before they reach the market. We help you obtain Sterilization Loan Licenses, allowing you to use approved third-party sterilization facilities. Our services cover both ETO (Ethylene Oxide) and Gamma Sterilization methods, ensuring that your devices meet the highest standards of sterility.
- ETO Sterilization: Ideal for devices that cannot withstand high temperatures, ETO is commonly used for single-use or plastic medical devices. We handle the license application process, ensuring that your chosen sterilization method meets regulatory requirements
- Gamma Sterilization: This method uses high-energy gamma radiation to sterilize devices, making it suitable for products that need deep sterilization, like surgical instruments or implants. We ensure the sterilization process complies with Indian medical device regulations, helping you secure the necessary licenses.
Test License (Form MD-12)
A Test License (Form MD-12) is required for conducting clinical trials, R&D, or product testing on medical devices that have not yet been licensed for sale. This license allows manufacturers to legally import or manufacture devices strictly for research and testing purposes. We assist you in compiling and submitting the necessary documents, including protocols for testing and R&D, ensuring your products meet safety and regulatory standards before going to market.