D-29, First Floor, Acharyaniketan, Mayur Vihar, Phase-1,
Delhi-91, India.
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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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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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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IVDs Kits/Reagents Covered Under Non-notified
Diagnostics
All In-Vitro Diagnostic Kits and
Reagents excluding those listed
under Notified category.Accredited Consultants Pvt. Ltd.
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 markersClass of IVDs/Reagents that Diagnose:•Malaria•Dengue•Chikungunya•Syphilis•Typhoid•Tuberculosis &
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Notified IVDsNon-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
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Legal Documents Technical DocumentsRegulatory 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 MarketSurveillance files ( PMS).
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• 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.
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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
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•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.
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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.
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OUR HEARTFUL THANKS
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Contact Details:Accredited Consultants Private Limited,D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091. Phones: 011-22758204, (M) +91-9310040434, +91-9266665201 Fax: 011-22758994
Email: [email protected]@acplgroupindia.co.in [email protected]
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