— What we Do
Select any specialized compliance pathway below to review our turn-key regulatory framework and market approval capabilities across Indian statutory authorities.
Official Device Classification
Medical Device Grouping
Predicate Identification
End-to-end dossier preparation, medical device classification, and MD-15 import licensing for Class A through D devices and diagnostics.
Mandatory Bureau of Indian Standards testing scheme coordination, lab testing supervision, and product registration for healthcare hardware.
ETA approvals and RF spectrum compliance for wireless connected medical monitors, telemetry units, and digital health hardware.
Device Registration
Independent Authorised Representative
Importation Support
Packaged commodity compliance, mandatory labeling declarations, and importer registration under the Legal Metrology Act.
Extended Producer Responsibility registration, e-waste target management, and CPCB reporting for medical equipment distributors.
Atomic Energy Regulatory Board type approvals, layout clearances, and radiation safety officer certifications for imaging equipment.