Notified Body Under CDSCO: Role, Registration, and Compliance for Medical Devices in India

The regulation of medical devices in India is governed by the Central Drugs Standard Control Organization under the Medical Devices Rules, 2017. A key part of this regulatory framework is the concept of the Notified Body, which plays a critical role in auditing manufacturers and ensuring compliance for medical devices.

If you are a medical device manufacturer or importer, understanding the role of a notified body under CDSCO is essential for licensing and market approval.

What is a Notified Body under CDSCO?

A Notified Body is an accredited independent organization authorized to audit manufacturing sites of medical devices and verify compliance with quality management systems and applicable standards under CDSCO regulations.

Under the Medical Devices Rules, 2017, notified bodies are responsible for assessing whether manufacturers of certain classes of medical devices meet the regulatory requirements before licenses are granted.

Legal Basis of Notified Body under Medical Devices Rules, 2017

Rule 13 of the Medical Devices Rules, 2017 defines the provisions for notified bodies in India.

According to the rules:

• Any institute, organization, or body corporate can apply for accreditation as a notified body.
• Accreditation is granted by a National Accreditation Body.
• Once accredited, the body must register with CDSCO as a notified body.
• Registration is issued in Form MD-2.
• Application for registration is submitted in Form MD-1.
• Registration remains valid perpetually, subject to retention fee payment every five years.

Role of Notified Body in Medical Device Approval

The notified body serves as an independent compliance verification agency. It performs audits and evaluates whether a manufacturer follows quality standards such as:

• ISO 13485 quality management system
• Product safety requirements
• Technical documentation review
• Regulatory compliance checks
• Manufacturing site inspections

These audits support CDSCO in granting licenses for medical devices.

Which Medical Device Classes Require Notified Body Audit?

Under Indian regulations, notified bodies primarily handle audits for:

Class A Medical Devices

Low-risk devices such as:

• Surgical dressings
• Thermometers
• Non-invasive diagnostic accessories

Class B Medical Devices

Low-moderate risk devices such as:

• Infusion pumps
• Nebulizers
• Blood pressure monitors

For these categories, notified body audits are required for manufacturing license assessment.

For higher-risk devices:

Class C and Class D

Notified bodies may also audit Class C and D devices after obtaining separate registration from CDSCO and fulfilling experience requirements.

Registration Process for Notified Body under CDSCO

Organizations seeking notified body recognition must follow this process:

Step 1: Accreditation

Apply to the National Accreditation Body for accreditation.

Step 2: CDSCO Registration

Submit application to CDSCO using:

• Form MD-1
• Required fee
• Documents under Third Schedule Part I

Step 3: Certificate Issuance

CDSCO issues:

• Form MD-2 registration certificate

Step 4: Retention

Registration remains valid if:

• retention fees are paid every 5 years
• accreditation remains active

Duties of a Notified Body

Under Rule 14 and Rule 15, a registered notified body must:

• Conduct audits of manufacturing sites
• Assess compliance with quality standards
• Review documentation
• Verify conformity with medical device rules
• Issue audit reports
• Recommend compliance observations
• Support regulatory decision-making

Suspension or Cancellation of Notified Body Registration

CDSCO may suspend or cancel a notified body registration if:

• it violates regulatory provisions
• audit procedures are not followed
• accreditation lapses
• retention fees are unpaid

An appeal may be filed before the Central Government within 30 days of the order.

Why Notified Body is Important for Medical Device Manufacturers

For manufacturers, the notified body is a critical compliance partner because it helps ensure:

Faster licensing

Proper audits support quicker application approvals.

Regulatory readiness

Manufacturers become compliant with Indian laws.

Quality assurance

Confirms adherence to ISO 13485 and product standards.

Market access

Enables lawful manufacturing and sale in India.

Documents Reviewed by Notified Body

During the audit, the notified body typically evaluates:

• Device Master File (DMF)
• Plant Master File (PMF)
• ISO 13485 certificate
• Technical documents
• Validation reports
• Risk management files
• SOPs
• Manufacturing records
• Product labeling
• IFU (Instructions for Use)

How MDR Consultants Can Help

At MDR Consultants, we assist medical device companies with end-to-end CDSCO compliance including notified body coordination.

Our services include:

• Manufacturing license applications
• Import license support
• DMF and PMF preparation
• Audit readiness
• ISO 13485 guidance
• CDSCO documentation
• Regulatory strategy
• Indian Authorized Agent services

We help ensure smooth interaction with notified bodies and successful regulatory approvals.

Frequently Asked Questions

Is notified body mandatory for Class A medical devices?

Yes, for manufacturing license applications, notified body audit is generally required under CDSCO compliance pathways.

Can notified body audit Class C and D devices?

Yes, if the notified body has additional registration and required experience approved by CDSCO.

What is the validity of notified body registration?

The registration is perpetual subject to:

• valid accreditation
• payment of retention fees every 5 years

Can registration be cancelled?

Yes, CDSCO may suspend or cancel registration for non-compliance.

Conclusion

The notified body under CDSCO plays a central role in India’s medical device regulatory ecosystem. It ensures manufacturers comply with quality and safety standards under Medical Devices Rules, 2017.

Whether you manufacture Class A, B, C, or D medical devices, proper notified body interaction is essential for successful regulatory approval.

For companies entering the Indian market, working with experienced consultants simplifies documentation, audits, and licensing processes.

Last Updated : 18 May 2026