India Medical Device Regulations

All documents listed below were published by the Ministry of Health and Family Welfare (MHFW) and are 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. Please help us maintain this list by reporting outdated or missing documents to marketing [at] emergogroup [dot] com. If you need help determining the regulatory requirements for your medical device in India, you may be interested in our custom regulatory strategy reports for India.

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