Medical device import support for India.
Medical device imports into India require careful review of classification, intended use, labelling, and CDSCO applicability. We help businesses approach this with documentation discipline and appropriate specialist coordination.
Medical and healthcare products we commonly support:
Diagnostic equipment and IVDs
Reagents, test kits, and diagnostic instruments.
Surgical instruments and theatre equipment
Single-use and reusable surgical tools and sterile supplies.
Laboratory equipment and consumables
Research instruments, analytical equipment, sample handling supplies.
Patient monitoring equipment
Bedside, ambulatory, and ICU monitoring systems.
Imaging and radiology-related equipment
Imaging systems and supporting infrastructure.
Medical consumables and accessories
Single-use and recurring-use medical consumables.
Home-use medical devices
Consumer-grade healthcare devices for home settings.
Hospital-use healthcare equipment
Equipment used across hospital and clinical settings.
Medical device components and spare parts
Sub-assemblies and replacement parts for medical equipment.
Clinical trial supplies and sample shipments
Investigational products, comparator drugs, ancillary supplies, and lab kits.
Depending on the product, the following may apply:
CDSCO Medical Device Rules 2017
Device classification and applicability.
Form MD-14 / MD-15
Import licence pathway for regulated devices.
Form MD-16
Test licence for clinical evaluation purposes.
Labelling and IFU review
Indian labelling requirement alignment.
Authorised Indian Agent coordination
Coordination support.
Free Sale Certificate / CFS
Sourcing and documentation support.
AERB coordination
For radiation-emitting equipment.
Customs and ADC query support
For held or queried shipments.
Post-market documentation
For ongoing compliance records.
How we handle medical imports.
- 01
Classification and licensing review
We assess device class, applicable approvals, and licence requirements before pickup.
- 02
IAA appointment if needed
For foreign manufacturers without an Indian agent, we step in as the Indian Authorised Agent.
- 03
Cold chain and packaging coordination
Temperature-sensitive shipments get verified packaging, monitoring, and lane selection.
- 04
Customs clearance with priority handling
Pre-filed Bills of Entry, expedited processing where regulations allow.
- 05
Delivery to hospital, lab, or trial site
Last-mile to your destination with full chain-of-custody documentation.
Who we support on medical device imports.
- Foreign medical device manufacturers
- Indian distributors and importers
- Hospitals and diagnostic chains
- Companies importing samples or demo devices
- Businesses planning CDSCO registration
- Clients facing customs or ADC / CDSCO-related queries
- Companies importing laboratory, diagnostic, surgical, or healthcare equipment
Specialist regulatory support may be required.
For complex Class B, C, or D medical device matters, Avexum Global coordinates with external CDSCO consultants, technical experts, or legal advisors. Transparent capability, documented responsibility, no overclaiming.
Medical IOR — your questions, answered.
Planning a medical device import?
Share your product catalogue, intended use, manufacturer details, country of origin, and current documentation status.