CDSCO Registration for Oncology Medical Devices - Process, Documents

The Indian government has announced its plan to bring all Medical Devices including Implants and Contraceptives under a review of CDSCO, making it mandatory to register under CDSCO for Oncology Medical Devices. Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical & Medical Devices and its positioning with the Ministry of Health and Family Welfare.

In the case of oncology medical devices, which are directly linked to cancer diagnosis, monitoring, and treatment, regulatory approval ensures that there is a strict evaluation of the product’s safety, performance, and clinical effectiveness.

Procedure of CDSCO Registration for Oncology Medical Devices

The Procedure to acquire CDSCO Registration can be understood by following steps:

Step 1: Sign Up on the SUGAM Portal : Visit the official website of CDSCO and log in or create an account on the ‘SUGAM’ registration portal.
Step 2: Select Registration Purpose : Click on the ‘Sign Up Here’ option to open the registration page. From the drop-down menu, select the appropriate registration purpose and proceed by clicking on ‘Submit’.
Step 3: Complete Applicant Details : Enter all the required details on the ‘Applicant Registration’ page. Once done, review all the details and submit the form to proceed further.
Step 4: Upload Required Documents : Upload all the required documents as mentioned to be verified by the CDSCO officials for the purpose of your application.
Step 5: Email Verification : A confirmation link will be sent to your registered email id. Click on the link to verify and activate your account on the CDSCO SUGAM portal.
Step 6: Final Approval by the Authority : After the activation of the account, the registration application will be submitted to the concerned CDSCO authorities for approval. After approval, a confirmation email will be received at your registered email address. If there is a rejection, a notification stating the same will be sent via email.

Documents Required for CDSCO Registration for Oncology Medical Devices

Following documents must be submitted to obtain CDSCO registration for oncology medical devices:

Form MD 40
Covering Letter
Details of the Medical Device
Copy of Authorization Letter issued by Director/Company Secretary
Quality Assurance Certificates
Instructions for Use
Undertaking from Testing Laboratory
Identity and Address Proof of the Applicant
ISO Certificate-13485

CDSCO Registration Fees for Oncology Medical Devices

The CDSCO registration fee for oncology medical devices is INR 1,02,999/- with Professional Utilities, inclusive of government fees.

CDSCO Registration for Oncology Medical Devices

Oncology Medical devices are used in diagnosing, treating and mapping the severity of cancer and tumors such as MRI’s, Pet Scans, Ultrasound etc. CDSCO Registration for Oncology Medical Devices is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.

CDSCO is constantly bringing out transparency, accountability and uniformity in its service to ensure safety, efficacy and quality of Medical Devices manufactured, imported and distributed in the country.

Importance of CDSCO Registration for Oncology Medical Device

Importance of CDSCO Registration for Oncology Medical Device can be studied as follows:

Ensuring Public Health: CDSCO is constantly striving to bring out transparency, accountability, and uniformity in its services to ensure safety, efficacy, and quality of medical devices manufactured, imported, and distributed in the country. The main job and objective of CDSCO is to safeguard Public Health.
Regulatory Compliance: CDSCO Registration provides Regulatory Compliance referring to a procedure following relevant laws and regulations; CDSCO ensures that the Medical Products that are used by the public shouldn't be hazardous to them.
Improving a Company's Reputation: Holding a CDSCO license serves as proof of completing the government policy and working under all the terms and conditions, which improves the reputation of the Company in the domain.

Simplify CDSCO Registration for Oncology Medical Devices with Expert Guidance

CDSCO Registration for Oncology Medical Devices is an essential regulatory process for companies planning to manufacture, import, and distribute cancer-related diagnostic and treatment devices in India. CDSCO approval will ensure that these devices conform to the laid-down standards of safety, quality, and performance as per the Medical Devices Rules, 2017.

As oncology devices are of utmost importance in the diagnosis, management, and treatment of cancer, the regulatory process will help ensure the health and safety of patients. Team of experts at Professional Utilities assist in proper adherence to the regulatory process of CDSCO which not only facilitates the legal entry of these devices in the Indian market but also help build brand credibility in the oncology healthcare industry.

FAQ’s On CDSCO Registration for Oncology Medical Devices

What are oncology medical devices under CDSCO?

Oncology medical devices under CDSCO are medical devices used to diagnose, treat, monitor, or manage cancer-related conditions. Medical devices are regulated under the Medical Devices Rules 2017 depending on their intended use.

Is CDSCO registration required for oncology medical devices in India?

Yes, CDSCO registration is mandatory for Class A, B, C, and D oncology medical devices in India. Manufacturers and importers must obtain a license to ensure saftery and quality standards.

How to get CDSCO approval for oncology medical devices?

Oncology medical devices approval requires an application along with the necessary technical documents by the applicant to the CDSCO through the SUGAM Portal. The application is evaluated as per the Medical Devices Rules 2017 based on the medical device classification, safety, and performance, before granting the license.

What is the process to obtain a CDSCO license for oncology medical devices?

The steps involved in obtaining a license for oncology medical devices are the identification of the medical device classification, preparation of the regulatory documents, and submission of the application to the CDSCO via the SUGAM Portal. The application is evaluated under the Medical Device Rules 2017 before the issuance of license.

What is the cost of CDSCO certification for oncology medical devices?

Total cost of CDSCO certification for oncology medical devices with Professional Utilities is ₹1,02,999/- only, including government fees.

Which oncology devices require CDSCO registration in India?

All medical devices used in oncology that are intended for diagnosis, treatment, monitoring, or management of cancer in India must be registered with CDSCO. This includes high- or moderate-risk devices like imaging devices, radiation therapy devices, biopsy devices, etc.

What are the risk classes for oncology medical devices under CDSCO?

CDSCO classifies oncology medical devices into four risk-based categories: Class A (low risk), Class B (low to moderate risk), Class C (moderate-high risk), and Class D (high risk). The regulation process is based on the Medical Devices Rules 2017.

What documents are required for CDSCO registration of oncology medical devices?

CDSCO registration for oncology medical devices includes submitting a dossier of documents via the SUGAM portal, which consists of Form MD-40 (for import) or Form MD-26 (for manufacturing), a covering letter, Device Master File (DMF), Plant Master File (PMF), ISO 13485 certification, and safety and clinical performance data.