CDSCO Registration in India: Process, Documents, Fees & Key Requirements

India’s medical device sector is governed by a structured regulatory framework designed to ensure that products placed on the market meet prescribed standards of safety, quality, and performance. The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, regulates medical devices under the Medical Devices Rules, 2017 (MDR 2017).

What is CDSCO Registration?

The term cdsco registration is commonly used for the regulatory approval process applicable to medical devices in India. However, under the current framework, most medical devices fall under a licensing regime rather than a simple registration-number system. CDSCO classifies devices according to their risk level as Class A, B, C, or D, ranging from low to high risk.

Since February 2020, all medical devices are regulated under MDR 2017, with an exemption from the licensing regime for Class A non-sterile and non-measuring devices.

Who Needs Medical Device Approval?

Manufacturers and importers seeking to commercially manufacture, import, sell, or distribute regulated medical devices in India may need the applicable CDSCO approval or licence.

For manufacturing, the applicable application forms depend on the device class. Class A and B devices generally follow the State Licensing Authority pathway, while Class C and D devices are handled by the Central Licensing Authority. Import applications for medical devices are submitted in Form MD-14, with the import licence issued in Form MD-15.

Therefore, medical device registration should always be planned according to the device's classification, intended use, manufacturing or importing model, and applicable regulatory requirements.

CDSCO Registration Process

The general process involves the following steps:

  1. Identify the device: Determine whether the product qualifies as a medical device under MDR 2017.
  2. Determine risk classification: Establish whether the device falls under Class A, B, C, or D.
  3. Prepare technical documentation: Depending on the application, documentation can include the Device Master File, Plant/Site Master File, technical specifications, performance information, quality-management documents, and evidence relating to safety and performance.
  4. Prepare legal documents: Applicant, manufacturer, authorization, and other applicable legal documents must be arranged.
  5. Submit the application: Applications are submitted through the applicable online regulatory portal and prescribed forms.
  6. Regulatory review: The licensing authority reviews the application and supporting documents and may raise queries or require additional information.
  7. Obtain approval/licence: Once the requirements are satisfactorily fulfilled, the applicable licence is granted.

Documents Commonly Required

The exact document checklist varies according to the application. Common requirements may include:

  • Applicant and manufacturer details
  • Device specifications and intended use
  • Device Master File
  • Site/Plant Master File, where applicable
  • Quality management system documentation
  • Test and performance reports
  • Evidence supporting safety and performance
  • Labeling and packaging information
  • Authorization documents for importers
  • Applicable certificates and declarations

CDSCO provides specific checklists and guidance documents for different medical-device applications.

CDSCO Licence Fees

The applicable cdsco license fee depends on the type of application, device classification, manufacturing site, and number of distinct devices. For example, the Medical Devices Rules prescribe fees for manufacturing licences, including separate amounts based on the device class and number of products. The applicable fee should therefore be verified against the current Second Schedule before filing.

Why Professional Assistance Can Help

CDSCO applications involve technical, legal, and regulatory documentation, and an incorrect classification or incomplete submission can result in queries and delays. ASC Group assists businesses with regulatory compliance and can help applicants understand the applicable pathway, documentation requirements, filing process, and regulatory obligations for medical devices.

Businesses planning to enter the Indian medical-device market should evaluate their product and regulatory category before beginning the application process to ensure the appropriate CDSCO pathway is followed.

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