India Medical Device Regulations

INDIA

The following document was published by the Ministry of Health and Family Welfare (MHFW) and is in PDF format. The Ministry of Health and Family Welfare is currently in the process of imposing more regulations on a broader range of devices. As more documents become available, we will post them here.

Major Regulations

• Drugs and Cosmetics Act - ACT No. 23 of 1940

Additional Information

• List of Notified Medical Devices (List of Gazetted Devices)
• Cosmetics Regulation in India (in English)

Specific Guidance Documents

• Clarification On Import And Manufacture Of Medical Devices

General Guidance Documents

• Guidance Document on Common Submission Format for Registration of Medical Devices in India