CDSCO Product Approval Process: Official Guidelines & Documentation

What is CDSCO Registration?

A CDSCO-registeredmedical device, drug, or other regulated product must also comply with all standards set forth by the CDSCO to ensure compliance with all applicable laws and regulations in India. The categories of CDSCO product registration fall under several categories that include beforeimporting or selling in India, and after import/ sale in India. AllCDSCO product registrations fall into one of two categories - pre-market applications for new and innovative products (ideally marketed in both India and abroad) and post-market surveillance. There are specific requirements for each category of application, as outlined by the CDSCO's CDSCO registration application procedures.

Who Needs CDSCO Registration?

The following groups must obtain CDSCO product approval for the following reasons:

• Indian manufacturers of notified medical devices

• Importers of drugs or medical devices

• Foreign manufacturers entering the Indian market

• Authorized Indian agents representing overseas companies

• Diagnostic kit manufacturers

• Manufacturers of Class A, B, C & D medical devices

Types of CDSCO Approvals

CDSCO provides various types of approvals based on the Product Category:

• Manufacturing License

• Import License

• Registration Certificate

• Test License

• Loan License

• Permission for Clinical Investigation

Classification of Medical Devices According to the Central Drug Standard Control Organisation (CDSCO)

The classification of medical devices according to the risk of use:

• Class A Low risk (e.g., surgical dressings)

• Class B Low-moderate risk (e.g., needles)

• Class C Moderate-high risk (e.g., ventilators)

• Class D High risk (e.g., implantable devices)

All manufacturers are required to determine their product's risk classification in order to applyfor approval from the CDSCO.

Required Documents for the CDSCO Registration Process

1. Business Documents

• Manufacturing/Import license copy

• Proof of establishment

• ISO 13485 certificate

• Plant layout

2. Technical Documents

• Device Master File (DMF)

• Plant Master File (PMF)

• Clinical evaluation report

• Performance study report

3. Regulatory Documents

• Test reports

• Undertaking letter

• Label and packaging details

• Free Sale Certificate (for imports)

These requirements apply across all categories of CDSCO medical device registration.

CDSCO Registration Process Step-by-Step

Below is the official CDSCO registration process using the online SUGAM Portal:

Step 1: Product Classification

Identify the product category as per CDSCO guidelines.

Step 2: Create an Account on SUGAM

Sign up on the CDSCO SUGAM Portal as a Manufacturer or Authorized Indian Agent.

Step 3: Upload Documents

Submit all required documents according to the product registration guidelines of CDSCO.

Step 4: Fee Payment

Pay the government fees for application review.

Step 5: Technical Review

CDSCO reviews technical documents, quality files, and safety data.

Step 6: Grant of License

Upon successful review, CDSCO issues a registration certificate or license.

After approval, you can legally manufacture, import, and sell your product in India.

Post-Approval Compliance

Even after obtaining CDSCO registration, the manufacturer must follow:

• Adverse event reporting

• Quality audits

• Compliance with Good Manufacturing Practices (GMP)

• Timely license renewal

• Labeling & packaging compliance

Failing to comply may lead to suspension or cancellation of the license.

Final Thought

As the Indian medical device industry continues to grow at a fast pace, there is an increased importance placed on the regulatory process by CDSCO in the registration of products. The successful registration of a medical device with CDSCO is a necessity for manufacturers, whether there is a domestic source of manufactured devices or an imported device from outside of India. In order for medical device manufacturers to obtain CDSCO registration promptly, manufacturers must carefully plan and prepare their technical documentation to be submitted during the CDSCO medical device registration process. Preparing for this thorough regulatory process will greatly enhance the opportunity for a manufacturer to enter the marketplace and expand their business.