2. What is In-Vitro Diagnostic Products (IVDs)
In vitro Diagnostic Products are those
substances that are intended to be used for
or use in diagnosis of disease or disorders in
human being or animals.
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3. DIAGNOSTICS REGULATION SYSTEM IN INDIA
The Drugs Controller General (India) of Central Drugs
Standard Control Organization (CDSCO) is the
Regulatory Authority that Governs the Import of IVD
Kits/Reagents in India to ensure the products which
are Approved, Manufactured and Imported are of
acceptable Quality, Safety and Efficacy.
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5. IVDs Kits/Reagents Covered Under
Notified Diagnostics
In-vitro Diagnostic Devices for HIV.
In-Vitro Diagnostic Devices for
HBV.
In-Vitro Diagnostic Devices for
HCV.
In-Vitro Blood grouping Sera.
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6. IVDs Kits/Reagents
Covered Under Non-notified
Diagnostics
All In-Vitro Diagnostic Kits and
Reagents excluding those listed
under Notified category.
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7. Accredited Consultants Pvt. Ltd.
All In-vitro diagnostic
Kits and Reagents that
are not listed under
Notified/Critical IVDs
and Semi-Critical
IVDs.
Non-Critical Semi-Critical
•Cancer markers
Class of
IVDs/Reagents that
Diagnose:
•Malaria
•Dengue
•Chikungunya
•Syphilis
•Typhoid
•Tuberculosis &
8. Accredited Consultants Pvt. Ltd.
Notified IVDs
Non-Notified
IVDs
Registration
Certificate in form-41.
Then Import Licence in
Form-10.
Only Import
Licence in Form-10.
Requirements for Import of IVDs in India
9. Accredited Consultants Pvt. Ltd.
Legal Documents Technical Documents
Regulatory
Documents
1. Form-40
2. POA
3. DI
4. DII
5. Whole sale
license (form
20B, 21 B)
1. Plant Registration
Certificate.
2. Manufacturing &
Marketing Licence.
3. Free Sale Certificate
from the country of
origin.
4. Free Sale Certificate
from anyone of the
GHTF countries.
5. CE Declaration of
Conformity.
6. CE Design
Certificate.
7. CE full quality
Assurance.
8. Copy of ISO/EN-
13485 Certification.
9. List of countries
where the device is
being sold.
1. Plant master file
( PMF).
2. Device Master File
( DMF).
3. Post Market
Surveillance files
( PMS).
10. Accredited Consultants Pvt. Ltd.
• The fee shall be paid through TR6 Challan in Bank of Baroda,
Kasturba Gandhi Marg, New Delhi.
• A fee of one Thousand and Five hundred US dollar ( or its
equivalent in indian rupee) shall be paid along with the application
in Form-40.
• A fee of one Thousand and US dollar ( or its equivalent in indian
rupee) shall be paid along with the application in Form-40 for
single Notified IVD Kit/Reagent intended for Import into and use
in India.
• An additional fee at the rate of One Thousand US dollars for each
additional Notified IVD Kits/ Reagents.
11. Accredited Consultants Pvt. Ltd.
Notified IVDs
1. Covering Letter.
2. Form-9.
3. Form-8.
4. TR 6 Challan.
5. Wholesale or
Manufacturing
Licence.
6. Registration
Certificate.
7. Labels .
Non-Notified IVDs
Non-Critical IVDs Semi-Critical IVDs
1. Covering Letter.
2. Form-9.
3. Form-8.
4. TR 6 Challan.
5. Free Sale
Certificate.
6. Wholesale or
Manufacturing
Licence.
7. ISO 13485.
8. Products Inserts,
Labels, COA.
9. Soft Copy of
Products.
1. Performance
Evaluation Reports
from National
Accredited Labs of
India for 3 batches.
2. And all other
documents as Non-
critical IVDs
12. Accredited Consultants Pvt. Ltd.
•The fee shall be paid through TR6 Challan in
Bank of Baroda, Kasturba Gandhi Marg, New
Delhi.
•A fee of INR 1,000.00 for One proposed kit and
INR 100.00 for each additional kit to be Imported.
13. Accredited Consultants Pvt. Ltd.
If the Application is complete in all
respects and informations are in order,
the licensing Authority may within
Three Months from the Date of
receipt of an application, issue an
Import Licence in Form-10.
