Device Classification
The medical device is classified based on its risk category (Class A, B, C, or D), defining the regulatory pathway.
Medical Devices – CDSCO
Regulatory Services for Importers
Seamless entry with regulatory excellence. BlackBows enables global manufacturers to navigate India’s medical device regulations with precision, ensuring compliant and efficient market access.
Medical Device Imports – A High-Growth Opportunity
India’s medical device sector is rapidly evolving under a strengthened regulatory framework, creating significant opportunities for global manufacturers to enter a high-growth healthcare market.
BlackBows enables businesses to align with updated CDSCO regulations through precise documentation, strategic regulatory planning, and seamless execution—ensuring faster approvals and compliant market entry.
CDSCO – How it governs Medical Devices regulatory affairs
In India, the Central Drugs Standard Control Organisation or CDSCO, manned by the Directorate General of Health Services under the aegis of the Ministry of Health and Family Welfare, governs the regulatory ecosystem for medical devices.
Strict procedures must be followed in accordance with the norms and guidelines established by the Central Drug Standard Control Organization while manufacturing Medical Devices (CDSCO).
CliniExperts has the experience and expertise to fulfil the entire regulatory process with a zero-defect capability.
Device Classification
Medical devices are categorized based on risk levels under CDSCO regulations.
Class A
Low Risk Devices
Includes basic products such as absorbent cotton and simple medical supplies.
Class B
Low–Moderate Risk
Devices like thermometers and diagnostic tools with moderate regulatory control.
Class C
Moderate–High Risk
Includes implants and advanced medical devices requiring stricter compliance.
Class D
High Risk Devices
Critical devices such as heart valves requiring maximum regulatory oversight.
Import License Process
A structured pathway for obtaining medical device import approval in India.
01
02
Authorized Agent
An authorized Indian agent is appointed to represent the manufacturer for regulatory submissions and coordination.
03
Application Filing
The import license application is submitted with complete documentation and compliance details.
04
License Approval
The application is reviewed by CDSCO, and approval is granted upon successful compliance verification.