Overview

India is counted as one of the top global Medical Devices markets with its major share towards Device imports. The country’s agency for device regulation, Central Drug Standard Control Organization (CDSCO) headed by Drug Controller General of India (DGCI) classifies Medical Devices into four classes (A, B, C and D) according the latest regulation. As the government introduces new regulations to give a fillip to the industry, entering the Indian Medical Device market seems a bit challenging. There is a need for local representative for marketing the devices in the country. The approval authority is shared between Center Licensing Authority (CLA) and State Licensing Authority (SLA). Without a detailed knowledge of updated regulations, the applicant may face ambiguity, which in turn leads to time and revenue losses.

With a dedicated global delivery and operational centre in India, Freyr offers extensive knowledge on the local Regulatory landscape. With a well-paved Regulatory strategy, Freyr provides end-to-end Regulatory services for pre- and post-marketing purposes of Medical Devices.

India Market Entry for Medical Devices - Process Flow

Vietnam Medical Device Regulations

 

Freyr Expertise

  • Medical Device Classification
  • Indian Authorized Agent Representation
  • Documents Compilation
  • Regulatory Assistance for Form MD-14 Application 
  • Liaison with Local Health Authority
  • Post-Market Surveillance

Summary

S. No

Regulatory Parameter

 

India

 

1

Regulatory Authority

 

CDSCO

 

2

Regulation

 

Medical Device Rules, 2017

 

3

Risk Classification

 

Class A

 

 

Class B

 

 

Class C

 

 

Class D

 

4

Regulatory Pathway

 

Application for Import License in MD - 14

 

5

Authorized Representative

 

Indian Authorized Agent (IAA) required

 

6

Fee payable

 

Class A

$1,050*

 

 

Class B

$3,000*

 

 

Class C & D

$4,500*

 

7

QMS Requirement

 

 Schedule 5 of MDR 2017

 

 

ISO 13485

`

8

Assessment of Technical Data

 

CDSCO

 

9

Validity of License

 

Unlimited

 

10

Labelling Requirements

 

Chapter VI of MDR 17

 

 

 

 

Legal Metrology Act

 

11

Submission format

 

Online

 

12

Final Outcome

 

Import License in Form MD 15

 

13

Timelines

 

6-9 months

 

14

Language

 

English

 

*The price is as per records at the time of documentation and is subject to change.