India CDSCO : Medical Device Registration for X-Ray

The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India.

With effect from 1st January 2021, All the X-ray machines fall under the category of mandatory registration of CDSCO Medical Devices.

 

The X-Ray device is classified as a Class C medical device as per the Risk-based classification of the Medical Device Rules, 2017.

CDSCO has set up different classes of medical devices as per their risk classification.

The classification of the Medical Device is risk-based and is classified into four types- Class A, Class B, Class C and Class D Medical Device, where the level of risk increases as it moves from Class A to Class D. Following table lists the classification of medical devices on the basis of the risk involved-

 

Class	Risk Involved
Class A	Low Risk
Class B	Low-Medium Risk
Class C	Medium-High Risk
Class D	High Risk

 

Procedure For CDSCO Medical Device Registration For X-Ray Machine

1.     Determine whether the Medical Devices require registration or not

2.     Risk-Based Classification of Medical Devices

3.     Appointment of Indian Authorized Agent (IAA)

4.     Technical Documentation

5.     Obtain Registration and License

 

Timeline For CDSCO Medical Device Registration For X-Ray Machine

The general timeline for CDSCO Medical Device Registration for X-Ray Machine is 6-9 months after completing the application process. The registration remains valid for three years. If in case of renewal, the applications are required to be submitted six months from the date of expiry.

 

*For more information, please refer to the file below.

 

THE MEDICAL DEVICES RULES, 2017.pdf

1.62MB

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If any questions regarding medical device certification,

Please contact us with the email below.

 

info@jnmglobal.net