Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good morning,
anybody familiar with Indian regulation to import a device that is used for training/education of clinicians? the device is not used on patients.
1) under US regulations, such type of device is not considered a medical device as it does not affect directly the treatment of a patient. Does India apply the same thinking?
2) which regulations apply and which type of testing/certification is required for importation?
Thanks in advance for any reference or guidance on this.

Hello,

Indian Drug Regulatory Authority also termed as "CDSCO" has issued a New Medical Device Rule 2017.
This Rule Book of 2017 details the procedure for classifying the MD as well as Importation norms for MD.

1.Medical Device Rule 2017.
2.FAQ for MD Rule 2018.

The website link of CDSCO pasted below will help you greatly to download the MD guidelines.

http://www.cdsco.nic.in/forms/list.aspx?lid=1580&Id=1



Hope this helps !

------------------------------
PURVI GORADIA
Manager Regulatory Affairs
Mumbai
India
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Original Message:
Sent: 20-Jul-2018 03:57
From: Anonymous Member
Subject: Indian regulations

This message was posted by a user wishing to remain anonymous

Good morning,
anybody familiar with Indian regulation to import a device that is used for training/education of clinicians? the device is not used on patients.
1) under US regulations, such type of device is not considered a medical device as it does not affect directly the treatment of a patient. Does India apply the same thinking?
2) which regulations apply and which type of testing/certification is required for importation?
Thanks in advance for any reference or guidance on this.