diagnostic kits

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.


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.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 &


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


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).


• 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.


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


•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.


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.


OUR HEARTFUL THANKS


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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