Overview
MD-15 Registration is a mandatory licence required for the import of medical devices into India. It is issued by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017.
Any business or individual intending to import notified medical devices for sale or distribution in India must obtain an MD-15 Import Licence before customs clearance.
At Adviso Compliance, we provide complete MD-15 registration services including CDSCO coordination, documentation, and approval support.
What is MD-15 Registration?
MD-15 is an import licence issued to importers of medical devices into India. The licence is granted after successful evaluation of the device, manufacturing site, quality standards, and regulatory compliance.
The licence ensures that imported medical devices are safe, effective, and compliant with Indian regulatory standards.
Who Needs MD-15 Registration?
MD-15 registration is required for:
Importers of medical devices
Authorized Indian agents of foreign manufacturers
Medical device distributors importing products
Healthcare equipment suppliers
Foreign manufacturers selling medical devices in India
Without MD-15 approval, medical devices cannot be imported or sold legally in India.
Medical Devices Covered Under MD-15
MD-15 applies to notified medical devices such as:
Diagnostic devices
Surgical instruments
Imaging equipment
In-vitro diagnostic devices (IVDs)
Medical consumables
Therapeutic and monitoring devices
Medical devices are classified into Class A, B, C, and D based on risk level.
Why MD-15 Registration is Important
MD-15 registration is essential because it:
Is legally mandatory for import of medical devices
Ensures patient safety and product quality
Enables customs clearance of imported devices
Builds trust with hospitals and healthcare institutions
Prevents penalties, confiscation, and legal action
Ensures compliance with CDSCO regulations
Operating without MD-15 approval can lead to strict enforcement.
Documents Required for MD-15 Registration
The required documents generally include:
Importer’s business registration certificate
PAN card and GST registration
Authorization letter from manufacturer
Free Sale Certificate from country of origin
Device Master File (DMF)
Plant Master File (PMF)
Quality certifications (ISO 13485)
Product labeling and packaging details
Our experts ensure proper documentation to avoid delays.
MD-15 Registration Process
At Adviso Compliance, the MD-15 registration process includes:
Step 1: Device Classification
We identify device class and regulatory requirements.
Step 2: Document Preparation
All technical and regulatory documents are compiled.
Step 3: Online Application Filing
Application is filed on the CDSCO SUGAM portal.
Step 4: CDSCO Review
Authorities review documents and may seek clarification.
Step 5: Import Licence Issuance
Upon approval, MD-15 licence is granted.
Validity of MD-15 Licence
MD-15 licence is generally valid for 5 years
Renewal must be filed before expiry
Changes in product or manufacturer require amendment
We assist with renewals and modifications as well.
Penalties for Non-Compliance
Non-compliance with MD-15 requirements may result in:
Import rejection at customs
Heavy fines and penalties
Suspension or cancellation of licence
Legal proceedings under drug laws
Proper registration helps avoid regulatory risks.
Why Choose Adviso Compliance for MD-15 Registration?
CDSCO regulatory experts
End-to-end MD-15 handling
Accurate technical documentation
Faster approvals
Transparent pricing
PAN-India service coverage
We ensure smooth and compliant medical device imports.
FAQs – MD-15 Registration
Yes, for notified medical devices intended for import.
Foreign manufacturers must appoint an Authorized Indian Agent.
Generally 30–60 working days depending on device class.
Yes, ISO 13485 certification is usually required.