Basics & Checklists for Medical Device Manufacturing license. Compiled by Rihim Pharma.
The MD 5 Manufacturing License in CDSCO India refers to the license required for the manufacturing of medical devices under the Medical Device Rules, 2017. This license is issued by the Central Drugs Standard Control Organization (CDSCO), which is the national regulatory body responsible for regulating medical devices and drugs in India.
The request for MD 5 license is made in MD 3 License for Class A and B devices; and MD 7 License for Class C and D devices. Your product should be rightly classified under MDR guidelines before applying for the MD 5. Consult with us for creating your regulatory strategy.
Class A & B (Low-risk medical devices) are those that have a low potential to cause harm to patients and do not require extensive regulatory oversight. Examples of such devices include surgical gloves, stethoscopes, and thermometers. To obtain the MD 5 Manufacturing License, the manufacturer must comply with the regulatory requirements outlined in the Medical Device Rules, 2017. This includes providing the necessary documentation and paying the requisite fees. The application is then reviewed by CDSCO, and if all requirements are met, the license is granted.
The MD 5 Manufacturing License is essential for manufacturers of low-risk medical devices in India as it ensures that the devices meet the safety and quality standards set by CDSCO. It also helps to ensure that the manufacturing process is conducted in a controlled and regulated environment, which can help to prevent the production of sub-standard or counterfeit medical devices. Overall, the MD 5 Manufacturing License plays a critical role in ensuring the safety and efficacy of low-risk medical devices in India.
Official Checklist of documents:
Class A & B (MD 3 Application Checklist): Download PDF
Class C & D (MD 7 Application Checklist): Download PDF
Do you find it easy to classify Medical Devices as per MDR?
- Yes, I find the guidelines easy
- No, I find the guidelines confusing or difficult
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