The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for drugs and medical devices. Under the Ministry of Health and Family Welfare, CDSCO ensures the country’s safety, efficacy, and quality of medical devices. This guide outlines the CDSCO registration process, the necessary forms, the required documents, and the procedure for bringing clinical gadgets to India. Understanding these means is critical for organizations hoping to enter the Indian medical device market.

What Is CDSCO?

The Central Drug Standard Control Organization, or CDSCO, is India’s National drug regulatory agency and fundamental body for medical devices. It is part of the Ministry of Health and Family Welfare, Government Of India. 

CDSCO Registration Process For Manufacturing License Medical Devices

The Central Drugs Standard Control Organization (CDSCO) is the regulatory body in India responsible for registering and regulating medical devices. Organizations should secure a manufacturing license from CDSCO to manufacture medical devices in India.

Indian CDSCO manufacturing licenses for medical devices are covered under the CLAA scheme and signed for a grant by the State Authorizing Authority. They might be considered for endorsement by CLAA with the condition that the licensee will satisfy all necessities of the medical device Rules. Manufacturing of notified medical devices comes under the CLAA scheme.

CDSCO Import License Registration For Medical Devices

Grant of test license for medical device investigation, etc.: The candidate will apply for an MD-16 in the SUGAM online portal for a permit in MD-17 to import medical devices for medical device investigation, test, evaluation, assessment, demonstration, or training.

CDSCO Forms For Registration Of Existing Medical Devices

The  Central Drugs Standard Control Organization (CDSCO) oversees the registration of medical devices in India. To register existing medical devices, you have to fill out specific forms.

• Form MD-1 – Application for the enrollment of a medical device by an authorized agent or manufacturer.
• Form MD-2 – This is the Application for the Import License of Medical Devices.
• Form MD-3 – This is the application for the manufacturing license for medical devices.
• Form MD-4 – is the Application for the Loan of a Manufacturing License for a Medical Device.
• Form MD-5 – This is the Application for the Renewal of License Registration for Medical Devices

These forms guarantee that all necessary information about the device, its efficacy, and its viability are provided. The forms must be submitted with the required fees and documents.

Following this process, you can legally import, manufacture, or market your medical device in India.

Classification Of Medical Devices As Per Indian CDSCO Regulations

These are the different classes of medical devices as per the Indian CDSCO Regulation. 

1. Class A (measuring/sterile): Low risk
2. Class B: Low, moderate risk
3. Class C: Moderate high risk
4. Class D: High risk

Mentioned above are classes based on their risk level to check class-wise medical devices. You can check.

Documents Required For Registration Under CDSCO

Here is the list of the required documents for registration under CDSCO; read below as all the asked documents are listed below:-

• Identification proof
• Address proof
• Undertaking from a government authority
• Copy of BA/BE site registration approved by CDSCO
• Manufacturing licenses or wholesale licenses for the import or manufacture of drugs or blood products
• Registration or test license
• Power of attorney
• Corporate address proof

Who Can Apply For CDSCO Registration In India?

These entities can easily apply for CDSCO registration in India. The List is given below:-

• Domestic manufacturers of medical devices and IVDs
• Importers of medical devices, IVDs, and cosmetics
• Foreign manufacturers of medical devices and IVDs
• Authorized agents of medical devices and IVDs
• Indian subsidiaries of medical devices and IVDs
• Indian agents
• Corporates
• Foreign enterprises holding an Indian subsidiary

What Are The Benefits Of CDSCO Registration?

Here are the benefits of CDSCO registration.

1. Market Access
2. Product Safety
3. Quality Management
4. Government Oversight
5. Credibility
6. Brand Identity

Which License Is Required To Sell Medical Devices In India?

MD-42 registration certificate is required to sell medical devices in India. Do secure all the essential documents, and if you face any difficulty, directly contact ELT corporate and get your answers in seconds.

Conclusion

Registering medical devices with CDSCO is essential for legal manufacturing, importing, and marketing in India. By following the outlined process and submitting the required forms and documents, manufacturers and importers can ensure compliance with Indian regulations. CDSCO registration facilitates market access and enhances product safety, quality management, and credibility. Professional services like ELT Corporate can provide valuable support for those seeking assistance with the registration process.