Medical Device Registration (MDR)
Complete Guide under CDSCO & Medical Device Rules (MDR), 2017
Medical Device Registration in India is mandatory for manufacturing, importing, selling, or distributing medical devices. The process is governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules (MDR), 2017, amended from time to time.
Our consultancy provides end-to-end assistance for Medical Device Registration, Licensing, and Compliance across India.
Regulatory Authority for Medical Device Registration
The regulatory authority responsible for medical devices in India is:
Central Drugs Standard Control Organization (CDSCO)
Ministry of Health & Family Welfare, Government of India
All registrations and licenses are processed through the CDSCO online portal (Sugam Portal).
Is Medical Device Registration Mandatory in India?
Yes. As per government notification, all medical devices are regulated in India. Any entity involved in:
- Manufacturing
- Importing
- Selling
- Distributing
must obtain the appropriate registration or license from CDSCO.
Classification of Medical Devices in India
Medical devices are classified based on risk level:
Class Risk Level Examples
Class A Low Risk Thermometers, surgical dressings
Class B Low-Moderate Risk Hypodermic needles
Class C Moderate-High Risk Orthopedic implants
Class D High Risk Heart valves, stents
Classification determines the license type, authority, and approval timel
Types of Medical Device Licenses
Depending on business activity, the following registrations/licenses are required:
1. Medical Device Manufacturing License
Required for manufacturers operating in India.
- Class A & B → State Licensing Authority
- Class C & D → Central Licensing Authority (CDSCO)
2. Medical Device Import License
Required for importing medical devices into India.
- Mandatory for all device classes
- Issued by CDSCO (Central Authority)
3. Medical Device Wholesale / Retail License
Required for traders, distributors, and sellers.
- Issued by State Drug Control Department
Documents Required for Medical Device Registration
Common documents include:
- Company Incorporation Certificate
- PAN Card & GST Registration
- Authorized Signatory ID & Address Proof
- Device Master File (DMF)
- Plant Master File (PMF)
- ISO 13485 Certificate
- Free Sale Certificate (for imports)
- CE Certificate (if applicable)
- Quality Management System documents
(Document requirements may vary based on device class and license type.)
Step-by-Step Medical Device Registration Process
Step 1: Identify device category (A, B, C, or D) as per MDR, 2017.
Step 2:Preparation of DMF, PMF, and compliance documents.
Step 3: Application filed through CDSCO Sugam Portal.
Step 4: Government fees paid
Step 5: Inspection or raise queries.
Step 6: Approval, registration/license is issued.
Timeline for Medical Device Registration
Device Class Approx Timeline
Class A 15–30 days
Class B 30–60 days
Class C 60–90 days
Class D 90–120 days
(Timeline depends on documentation quality and authority review.)
Validity of Medical Device License
- License is valid perpetually
- Subject to retention fee payment every 5 years
- Compliance audits may be conducted periodically
Government Fees for Medical Device Registration
Fees vary based on:
- Device class
- Number of products
- Manufacturing or import license
Exact fee calculation is done during application filing.
INDUSTRIES THAT REQUIRE MEDICAL DEVICE REGISTRATION
Medical Device Registration is mandatory for any entity involved in manufacturing, importing, distributing, selling, or servicing medical devices.
- Disposable medical products manufacturers
- Surgical instruments manufacturers
- Diagnostic equipment manufacturers
- Imaging equipment manufacturers (X-ray, CT, MRI, Ultrasound)
- Orthopedic implants manufacturers
- Cardiac devices manufacturers (stents, pacemakers)
- Dental equipment & consumables manufacturers
- Ophthalmic devices manufacturers
- IVD (In-Vitro Diagnostic) device manufacturers
- Medical electronics & electro-medical equipment manufacturers
- Importers of medical equipment
- Importers of diagnostic kits & reagents
- Importers of surgical instruments
- Importers of implants & life-saving devices
- Importers of hospital & ICU equipment
- Medical equipment distributors
- Surgical goods wholesalers
- Diagnostic device distributors
- Authorized medical device dealers
- Stockists & resellers of medical devices
- Multi-specialty hospitals
- Private & government hospitals
- Nursing homes
- Day-care surgical centers
- Diagnostic & pathology laboratories
- Pathology labs
- Radiology & imaging centers
- Blood banks
- Clinical laboratories
- Molecular diagnostic labs
- Dental clinics using dental implants & devices
- Eye hospitals & clinics using ophthalmic devices
- Online medical equipment sellers
- E-pharmacy platforms selling medical devices
- B2B medical device marketplaces
- Third-party medical device manufacturers
- OEM manufacturers for branded devices
- White-label medical device manufacturers
- Medical research institutions
- Clinical research organizations (CROs)
- Medical device testing & validation labs
Why Choose Us for Medical Device Registration?
- Expert regulatory consultants
- Complete documentation support
- Faster approval handling
- CDSCO portal filing assistance
- Post-license compliance support
We ensure 100% compliance with Medical Device Rules, 2017 and latest CDSCO guidelines.
We Serve Businesses in Indian States Including:
Andhra Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Jharkhand, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Odisha, Punjab, Rajasthan, Tamil Nadu, Telangana, Uttar Pradesh, Uttarakhand, West Bengal, Delhi, Chandigarh
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Get expert assistance for:
- Medical Device Registration
- Import License
- Manufacturing License
- ISO 13485 Certification
- CDSCO Compliance Consulting
Talk to our experts today and get your medical device approved hassle-free.