Important Links of Medical Devices and Medicated Cosmetics Division

Medical Devices Rules, 2017

Medical Devices Rules, 2017 approved and Notified on 16-01-2018 (New)

Application Forms

-- Establishment Licence

Form-1 Application for Grant/ Renewal Of Establishment Licence to Locally Manufacturer Medical Devices

Form-2 Application for Grant/ Renewal Of Establishment Licence to Import Medical Devices

-- Enlistment of Class-A Medical Devices

Form-6 Application for Grant/ Renewal Of Enlistment of Locally Manufacture Class-A Medical Devices

Form-6A Application for Grant/ Renewal Of Enlistment of Imported Class-A Medical Devices

-- Registration of Class-B,C & D Medical Devices

Form-7 Application for Grant/ Renewal Of Registration of Locally Manufacture Class-B,C & D Medical Devices

Form-7A Application for Grant/ Renewal Of Registration of Imported Class-B,C & D Medical Devices

-- Provisional Establishment Certificate (PEC)To Import Medical Devices Provided In Schedule D

Form-19 Application Form For Grant Of Provisional Establishment Certificate To Import Medical Devices Provided In Schedule D

-- Provisional Registration for Medical Devices Provided in Schedule-D

Form-21 Application Form For Provisional Registrationof A Medical Device For Import Provided In Schedule D

Schedule of Medical Devices Rules, 2017

Schedule-A Classification System For Medical Devices

Schedule-B Grouping Of Medical Devices

Schedule-C Fee Structure of Various Activities

Schedule-D List Of Life Saveing Or Life Sustaining Medical Devices

Guidance Documents

Guidelines on Good Distribution Practices for Medical Devices 27-12-2016 

Check List For Good Distribution Practices For Medical Devices (05-04-2018) 

More Details are also availabe in the Downloads and Notification Sections..