In the healthcare industry, medical devices are the core part. During the operation and
treatment, they are used to treat humans. As medical equipment is a major part of the
healthcare industry, the Indian government is introducing new rules. In India, the Central Drugs
Standard Control Organisation is the one that manages all activities of medical devices in
India. It means that, whether you are a medical equipment manufacturer, importer, or distributor, you need to obtain a medical device manufacturing license.
In this comprehensive guide, we will explore how you can secure the medical device license in India, the process, benefits, and more. Let’s explore this page in more detail.
Why is the CDSCO Medical Device Manufacturing License Important for Manufacturers?
Imagine you want to enter India’s booming market, but you don’t have a valid license. This is where the CDSCO registration certificate for medical equipment works. This indicates that manufacturers of medical devices must register with the governing body, known as the Central Drugs Standard Control Organisation. With a valid license, the manufacturer has market access. Not only in domestic markets, but you will also get the opportunity to go international, Mama. These facilitate the route for international markets, which is crucial to increase the company’s credibility. The medical device license also ensures the equipment’s safety and quality standards. The standardisation of the device is designed to protect the customers from possible injury. Before the use of medical equipment on the patients, they are sent to the lab for testing to ensure defectiveness.
The Process to Obtain the Medical Device Manufacturing License
To obtain the medical device certificate in India, the manufacturer needs to follow several steps. The process involves online registration, document submission, and facility inspection. It is also crucial to meet the compliance with Good Manufacturing Practices (GMP) and ISO 13485 standards. The key registration steps are:
1. Determine the Medical Type to Obtain the Medical Device Manufacturing License
Typically, devices are distinguished into four distinct categories based on their associated hazards. Classify your equipment, whether it is class A, B, C, or D, as per the Medical Devices Rules, 2017.
2. Register on the CDSCO Online Portal to get a Medical Device Manufacturing License
To submit the application form, visit the CDSCO official online website.
3. Prepare the application
- For types A and B equipment, fill out the Form MD-3
- Use the Form MD-7 for C and D types of equipment
- To obtain the loan certificate, kindly use Form MD-8
4. Prepare the important documents
- The Device Master File (DMF)
- The Plant Master File (PMF)
- Proof of site ownership
- Proof of Quality Manufacturing Practices (QMS)
- Identity Proof, including premises address proof
5. Pay the fees
The fee depends on the type of medical devices and other major factors.
6. Application submission online
Attach all documents with the application form. Before submitting the form, ensure that you review it to prevent any potential rejection or delays.
7. Premises Inspection
To ensure compliance with standards and equipment facilities, the authority will conduct a premises inspection.
8. Review and Approval
The inspection report and the application with documents will be reviewed by CDSCO. If everything meets the specific standards, the manufacturing license will be issued by the CDSCO.
9. Medical Device Certificate Renewal
The manufacturers can only use the license for five years. Before the expiry date, apply for license renewal to continue the equipment’s operations.
Conclusion
As the medical devices are risky tools, they are also regulated by the State Licensing Authority. The State Licensing Authority also involves providing the license for Class A and B devices. The Central Licensing Authority (CDSCO) is the one that grants the certificate for Class C and D devices. Laboratory testing of the equipment is also a significant component. For testing or clinical investigation, manufacturers need to use the Form MD-12. The entire process can feel overwhelming to those who lack knowledge related to registration. Professional guidance and assistance can alleviate the process. CDSCO license application online now to operate the medical device business without legal risks.
