CDSCO Medical Device Registration Services

What is CDSCO?

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory organization for pharmaceuticals, cosmetics, and medical devices, which ensures public health safety. It operates under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO is responsible for the approval of drugs, clinical trials, setting standards for drugs, regulating imported drugs, and coordinating state drug control activities.
The Drugs & Cosmetics Act, 1940, and rules from 1945 delegate responsibilities to both central and state regulators to ensure uniform implementation. This regulation covers pharmaceuticals, cosmetics, and medical devices, ensuring they adhere to standards that safeguard patients' safety and rights. CDSCO aims for transparency, accountability, and uniformity, constantly working to guarantee the efficacy, safety, and quality of products manufactured, imported, and distributed in India.

Medical Device Classification

CDSCO classifies medical devices based on the risk they pose to patients. Devices are divided into four classes:

• Class A: Low Risk
• Class B: Low to Moderate Risk.
• Class C: Moderate to High Risk
• Class D: High Risk

As per the G.S.R. 777(E) notification from October 14, 2022, Class A non-sterile and non-measuring devices are self-notified. For all other medical devices, manufacturers must go through the CDSCO review process. The SUGAM portal allows Indian agents and manufacturers to automatically obtain registration numbers for exporting and manufacturing Class A devices.

Products Covered Under CDSCO-Medical Device Registration

India Medical Device Registratsion

All applications for both Notified and Non-Notified medical devices must be submitted through the CDSCO’s online SUGAM portal. Here we breakdown the two categories:

Non-Notified Devices: Devices not included in the Notified list are not currently regulated in India. However, manufacturers can still list these devices on the CDSCO portal.

Licensed Representative:Notified Devices: There are 37 categories of Notified medical devices that require CDSCO approval before being marketed in India. Different forms and document requirements apply based on the type of device, whether it’s for import, testing, or manufacturing.

How to Register for a CDSCO Manufacturing License

To register for a CDSCO manufacturing license, manufacturers must ensure they meet eligibility criteria, including adherence to Good Manufacturing Practices (GMP) guidelines, employing qualified technical staff, and preparing the required documentation. The key forms include:

Form MD 3: Application for manufacturing Class A or Class B medical devices.

Form MD 5: License issued for manufacturing Class A or Class B devices.

Form MD 7: Application for manufacturing Class C or Class D medical devices.

Form MD 9: License for manufacturing Class C or Class D devices.

How to Apply for a CDSCO Manufacturing License via the CDSCO Portal

To apply for a manufacturing license for medical devices in India via the CDSCO portal, follow these steps:

1. Create an Account: Register on the CDSCO SUGAM portal using your email address.
2. Log In: Access the "Online Application" section after registration.
3. Select Medical Devices: Choose the type of license you wish to apply for.
4. Fill the application form: Enter all of the required data properly.
5. Upload Documents: Submit the necessary documents as required by CDSCO.
6. Pay the Fees: Make the payment through the online gateway.
7. Submit: Once completed, submit your application for CDSCO review.

The approval process typically takes 3 to 4 months, depending on the type of device and the thoroughness of the application.

Conclusion

The CDSCO Medical Device Registration process is essential for regulating the manufacturing, import, and distribution of medical equipment in India. From biomedical devices to hospital equipment, manufacturers must comply with CDSCO's regulations to ensure product safety and efficacy. Whether you are a medical equipment manufacturer or involved in the supply chain of doctor’s equipment, having CDSCO certification is crucial to bringing products to market and maintaining high standards in India's healthcare sector. For a streamlined CDSCO registration process, ensure you follow the necessary steps, meet the criteria, and submit all required documentation through the CDSCO medical device portal.