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WELCOME

ACCREDITED CONSULTANTS PVT. LTD.

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.

Accredited Consultants Pvt Ltd

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.


Classification of IVDs

Non-Notified

Not-Critical Semi-Critical

Notified/ Critical


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.


IVDs Kits/Reagents Covered Under Non-notified Diagnostics

All In-Vitro Diagnostic Kits and Reagents excluding those

listed under Notified category.


Further Classification of Non-Notified IVDs


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 &


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

Documents required for Registration

Accredited Consltants 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).

Fee required and Mode of payment for Registration


• 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.

Documents required for Import Licence


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

Fee required and Mode of payment for Import Licence


•The fee shall be paid through TR6 Challan in Bank of Baroda, Kasturba Gandhi Marg, New Delhi.

•A fee of INR 1000 for One proposed kit and INR 100 for each additional kit to be Imported.

Time Period For Grant of Import Licence


If the Application is complete in all respect and

information 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.


OUR HEARTFUL THANKS

WE BELIEVE OUR CLIENTS ARE OUR

KINGS!!!

D-29, First Floor, Acharyaniketan, Mayur Vihar, Phase-1, Delhi-91, India.

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