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Sr.No
CLARIFICATION DOCUMENTS
1
Clarification For Import of Freezing Bags Transfer Set
2
Clarification on Guidelines for Import & Manufacture of Medical Device
3
Clarification on Regulation of Stapler (Staples)
4
Regulation of Medical Device covered Under Notified Medical Device- Reg
5
Clarification for Import of Pre filled Syringes Components
6
Clarification for Import of Raw Materials in bulk form in Rolls/Bundle for Manufacture of Finished Product (Sutures)NEW
7
Clarification for Import of Non-Notified Medical Devices
8
Guidance document on common submission format for Manufacture of Medical Devices (Form-28) Under CLAA Scheme
9
Guidance document on common Submission Format for Registration(Form-41)(Excluding Notified IVD's), Import Licence(Form 10)(Excluding IVD's) and Manufacture of Medical Devices (Form- 28) Under CLAA Scheme
10
Additional Clarification with Regard to Control of Various Medical Devices (20.03.2008)
11
Guidelines for Import and Manufacture of Medical Devices (01.03.2006
12
CLARIFICATION REGARDING NOC FOR IMPORTS OF DIAGNOSTIC KITS / REAGENTS (IVD's)
13
USE OF DIAGNOSTIC KITS OF HBsAg, HIV AND HCV IN BLOOD BANKS OR PATHOLOGICAL LABS (IVD's)
14
CLARIFICATION ISSUED BY CDSCO ON IVD (IVD's)
15
USE OF RAPID TEST KITS FOR TESTING OF HIV AND HCV IN BLOOD BANKS (IVD's)