CDSCO registration: how to bring your medical device to India

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority in India responsible for the regulation of pharmaceuticals, medical devices and cosmetics. In recent years, the CDSCO has streamlined its regulations for medical devices to ensure safety, efficacy and quality. Understanding these requirements, the submission process and its timelines is crucial for manufacturers and importers aiming to enter the Indian market.

Let's take a look at what you need to know.

CDSCO medical device registration classes

Like many national regulators, the CDSCO classifies medical devices into four categories based on risk: 

1. Class A (low risk) 
2. Class B (low-moderate risk)
3. Class C (moderate-high risk)
4. Class D (high risk)

The classification determines the regulatory requirements, and the documentation you'll need to assemble for entry to the Indian market.

CDSCO registration documents

You'll need a series of key quality and risk documents to prove the safety and efficacy of your medical device.

These include:

• Device master file (DMF)
• Plant master file (PMF)
• Clinical evaluation report
• Risk management report
• Performance evaluation report (if applicable)
• Quality Management System (QMS) accreditation: compliance with ISO 13485 or equivalent standards is mandatory for manufacturing medical devices
• BIS certification: Certain medical devices must comply with Indian Standards (IS) set by the Bureau of Indian Standards (BIS)
• Labeling: devices must be labeled in accordance with Medical Devices Rules 2017, including information such as manufacturer details, batch number and expiry date

CDSCO medical device registration process

The submission process to CDSCO involves several steps:

Application submission

For new devices, manufacturers/importers must submit an application in Form MD-14 (for Class A/B) or Form MD-15 (for Class C/D) via the online Sugam portal.

Along with the application, required documents such as the DMF, PMF, clinical data, and QMS certification must be submitted.

Review and scrutiny

CDSCO reviews the submitted documents for completeness and compliance with regulatory requirements.

For Class C and D devices, a detailed technical review is conducted, which may involve consultations with subject matter experts and the Technical Advisory Committee (TAC).

Inspection and verification

CDSCO may conduct inspections of manufacturing facilities to verify compliance with QMS and Good Manufacturing Practices (GMP).

For imported devices, CDSCO may inspect foreign manufacturing sites or rely on inspection reports from other recognized regulatory authorities.

Approval and licensing

Upon successful review and inspection, CDSCO issues the registration certificate and import/manufacturing license in Form MD-5 (for Class A/B) or Form MD-6 (for Class C/D).

The license is valid for five years, after which renewal is required.

CDSCO medical devices submission timeline

As you'd expect, the timeline for the submission and approval process varies depending on the class of your medical device and the complexity of the review.

Class A and B devices

The review process typically takes 3-6 months from the date of submission.

Inspections, if required, may extend the timeline by an additional 1-2 months.

Class C and D devices

The review process can take 6-12 months, given the detailed technical scrutiny involved.

Inspections and TAC consultations may further extend the timeline by 2-3 months.

Getting ready for CDSCO registration

Navigating the regulatory landscape of medical devices in India requires thorough preparation and understanding of CDSCO requirements.

By ensuring compliance with your documentation, QMS and labeling standards, and by following the structured submission process, manufacturers and importers can successfully gain access to one of the world's fastest-growing medical device markets.

Awareness of these timelines helps in strategic planning and efficient market entry.