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Medical Device Registration

Medical Device Registration is the CDSCO approval that lets manufacturers and importers legally make, import, sell or distribute medical devices...

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Key takeaways

Medical Device Registration is governed by CDSCO under the Drugs and Cosmetics Act and the Medical Device Rules (MDR).
Any manufacturer, importer or distributor of medical devices in India must obtain CDSCO Medical Device Registration.
Devices fall into four risk classes, A, B, C and D, which decide the licensing authority and forms.
Class A and B licenses are issued by the State Licensing Authority (SLA); Class C and D by the Central Licensing Authority (CLA) under the DCGI.
Applications are filed online through the CDSCO SUGAM portal.
From 1 October 2023, all medical devices require mandatory registration for import and sale in India.
Processing typically takes 6 to 9 months and the registration is valid for 5 years unless suspended or revoked.

Overview

What is Medical Device Registration?

Medical Device Registration is the regulatory process that grants manufacturers and importers the legal authority to manufacture, sell or distribute medical devices in India. It assures that devices authorised for sale have been evaluated for safety, efficiency and quality.

The Central Drugs Standard Control Organization (CDSCO), an arm of the Drug Controller General of India (DCGI) under the Ministry of Health and Family Welfare, is the national authority that frames guidelines and handles registration, approval, regulation and supervision of drugs, in-vitro diagnostics (IVDs) and medical devices. The process covers classification, documentation, submission, review and approval, protecting patients from non-compliant devices and aligning India with global standards.

The CDSCO registration process evaluates

Device design and specifications
Manufacturing practices
Quality management practices
Performance and safety data
Labelling and packaging compliance
Regulatory certificates such as ISO 13485

Classification

Device classes and licensing authority

Medical devices are classified into four risk classes. The class decides whether the State or the Central Licensing Authority issues your license.

Risk class	Examples
Class A (low risk)	Stethoscope, bandage, thermometer
Class B (low to moderate risk)	Syringes, blood pressure monitors
Class C (moderate to high risk)	Orthopedic implants, catheters
Class D (high risk)	Pacemakers, ventilators, heart-lung machines

Class	Approval authority
Class A and B (low to medium risk)	State Licensing Authority (SLA)
Class C and D (moderate to high risk)	Central Licensing Authority (CLA) under the DCGI

Why it matters

Benefits of CDSCO registration

Market access

Legal authority to sell and distribute medical devices across one of the largest and fastest growing healthcare markets in the world.

Brand credibility

Proof that you meet India’s safety, efficacy and quality requirements, building trust with healthcare providers and patients.

Regulatory compliance

Keeps products aligned with the Medical Device Rules, Good Manufacturing Practices and other Indian requirements.

Competitive advantage

Public and private tenders need CDSCO registered devices, giving licensed brands a clear edge in procurement.

Patient safety

Ensures devices reaching hospitals and patients are safe, reliable and effective in treatment.

Stronger partnerships

Opens high-value partnerships and cross-border supply where compliant, registered devices are required.

Compliance

Why registration is mandatory

CDSCO Medical Device Registration is a requirement mandated by law for any entity in the business of medical devices in India. Earlier only 15 types of devices were regulated, but the framework has been expanded so that all categories of devices now fall under CDSCO oversight and Indian rules align with global compliance standards.

Key regulatory milestones

From 1 October 2022, all Class A and B devices plus notified Class C and D devices require an import license.
From 1 October 2023, licensing extended to non-notified Class C and D devices.
As per the latest CDSCO notification, all medical devices require mandatory registration for import and sale in India effective 1 October 2023.
Unregistered devices cannot legally be sold or distributed in India.

How it works

The registration process, step by step

The process runs online through the CDSCO portal. The core certification path and the import licensing path are summarised below.

CDSCO certification

Classify the device
Determine the correct risk class, A, B, C or D, which sets the authority and forms.
Submit the application
File online on the CDSCO portal with regulatory certificates, QMS proof and device specifications.
CDSCO review
CDSCO verifies the documents, device design, manufacturing and quality data.
Approval or rejection
On successful verification the registration or license is granted.

Import license

Documentation
Prepare regulatory certificates, QMS proof and device specifications.
Submission
Apply online via the CDSCO portal and upload the required documents.
Fees
Pay the prescribed application fees for the device class.
Review and approval
CDSCO verifies the documents and issues the import license.

Paperwork

Documents required

ISO 13485 Certificate
Full Quality Assurance Certificate
CE Design Certificate
Power of Attorney
Free Sale Certificate
Plant Master File (PMF)
Device Master File (DMF)
Post-Market Surveillance (PMS) details

Related approvals: see our ISO 13485 Certification and CDSCO Registration services.

Lifecycle

Validity & renewal

The registration is valid for 5 years from issue, unless suspended or revoked.
Licenses must be renewed at least 9 months before expiry.
Renewal requires submission of the Plant Master File (PMF) and Device Master File (DMF) to confirm no significant changes.
Inform CDSCO of any change in company constitution, registered office or manufacturing site.
If the registration certificate changes, it remains valid for only 3 months, during which an updated registration must be secured.

Also explore our Drug License and Cosmetic License services.

Forms

CDSCO forms for registration

The form set depends on whether you are an importer, a manufacturer or a loan licensee, and on the device class.

Form	Purpose
MD-14 / MD-15	Importer license (Class A to D devices)
MD-3 / MD-5	Manufacturer’s license (Class A and B devices)
MD-4 / MD-6	Loan license (Class A and B devices)
MD-7 / MD-9	Manufacturer’s license (Class C and D devices)
MD-8 / MD-10	Loan license (Class C and D devices)

Not sure which class or form applies?

Tell us whether you manufacture or import, and the device type, and we will map the exact class, forms, documents and timeline for your registration.

Get a free assessment

FAQ

Frequently asked questions

Is CDSCO registration valid for every medical device in India?

Yes. All medical devices must be registered with CDSCO, with mandatory registration for import and sale effective 1 October 2023.

How long does CDSCO medical device registration take?

Usually 6 to 9 months. The timeline can vary based on the device type and the level of documentation submitted.

Who needs to register a medical device?

Domestic manufacturers, importers, foreign manufacturers, authorized agents and Indian subsidiaries dealing in medical devices in India.

How are medical devices classified?

Devices fall into four risk based categories, from Class A (least risk) to Class D (highest risk). The class decides the licensing authority and forms.

Can foreign manufacturers apply?

Yes. Foreign manufacturers can apply directly or through an Indian Authorized Agent (IAA) or their Indian subsidiary.

Where is the application submitted?

The SUGAM portal is the official online portal for CDSCO application submission and document upload.

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