FOR INTERNAL USE ONLY. NOT FOR PRINT OR DISTRIBUTIONFOR INTERNAL USE ONLY. NOT FOR PRINT OR DISTRIBUTION
Overview of India IVD regulations
Mayank K Saini

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Contents..
The Regulatory Process of IVDs approval
CDSCO Organization Chart and their Function.
Classification of IVDs in India.
Documents and Basic Steps of Issuance of Import License.
Basic Steps of Issuance of Mfg. License
Time Line for Various Licenses’ Approval
Overview of India GMP.
1

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India
The Regulatory Process of IVDs approval.
 Prior to 2005, no medical device regulations existed in India.
However, today there are registration procedures for certain
types and classes of medical devices regulated under the
provisions of the Drugs and Cosmetics Act & Rules.
 The Drugs Controller General (India) of Central Drugs
Standard Control Organization (CDSCO) is the Regulatory
Authority that Governs the Import and Manufacturing of IVD
Kits/Reagents in India to ensure the products which are
Approved, Manufactured and Imported are of acceptable
Quality, Safety and Efficacy.
2

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CDSCO Organization Chart and their Function
3
DCG(I)
Head Quarter
Central office
(New Delhi)
Central Authorities are responsible for approval
of New Drugs, Clinical Trials in the country,
laying down the standards for Drugs, control over
the quality of imported Drugs
Zonal offices
North,South,
East, West
HYD, AMBD
States Offices
FDA- Haryana
( SDC- Cum
Licensing Authority)
(North Zone)
The regulation of manufacturing sale and distribution of
drugs is primarily the concern of the State authorities with
the coordination of North Zone office and central
laboratories to assist in securing uniform enforcement of
the Drug Act and other connected legislations, on all India
basis
Port offices
Delhi Port and
rest 12 others
Port offices
Laboratories
CDL,CDTL,RTDL
NIB, IVRI, IPC

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Classification of IVDs in India
In India CDSCO has classified the IVD kits in the following manner.
4
Classification of IVDs
Notified IVD Devices
Non-Notified IVD
Devices
Non-
Critical
Semi
Critical

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Further Classification of Notified & Non-Notified
IVDs
5
Notified
IVDs
1.IVD kits of HIV
2.IVD kits of HCV
3.IVD kits of HBsAg
Non-Notified
IVDs
Semi-critical
1.Cancer Markers
2.Dengue
3.Chikungunya
4.Malaria
5.Typhoid
6.Tuberculosis
Non-Critical
All In-vitro diagnostic Kits
and Reagents that are not
listed under
Notified/Critical IVDs and
Semi- Critical IVDs

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Documents Required for Import of IVDs
Registration
6
Legal Documents
• Form-40
• POA
• DI
• DII
• Whole Sale Licence(Form 20 B,21
B)
Regulatory
Documents
• Plant Registration Certificate
• Manufacturing & Marketing
Licence
• Free Sale Certificate from the
country of origin
• Free Sale Certificate from anyone
of the GHTF countries
• CE Declaration of Conformity
• CE Design Certificate.
• CE full quality Assurance
• Copy of ISO/EN-13485
Certification
• List of countries where the device
is being sold
Technical
Documents
• Plant master file ( PMF)
• Device Master File ( DMF)
• Post Market Surveillance files

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Documents Required for Import
Licence(Form 10)
7
Notified IVDs
• Covering Letter
• Form-9
• Form-8
• TR 6 Challan
• Wholesale or Manufacturing
Licence
• Registration Certificate.
• Labels
Non-Critical IVDs
• Covering Letter
• Form-9
• Form-8
• TR 6 Challan
• Free Sale Certificate
• Wholesale or Manufacturing
Licence
• ISO 13485
• Products Inserts, Labels,
COA
• Soft Copy of Products
Semi-Critical IVDs
• Performance Evaluation
Reports from National
Accredited Labs of India for
3 batches
• And all other documents as
Non-critical IVDs

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8
INon/Semi Critical IVDs Critical IVDs
Appoint an India Authorized Agent who must have a
valid wholesale license (Forms 20B and 21B).
Grant Power of Attorney to your India Authorized
Agent to manage registration in India.
File application for Device Registration Certificate
to CDSCO using Form 40. Schedules D-1 and D-2
must be included, as well as verification of
compliance with US, Canadian, European,
Japanese or Australian regulations.
Device manufacturers new to India require a Form
45 (New Drug License) in support of the Form 40
application.
Obtain Registration Certificate Form 41 from
CDSCO. Certificate is valid for up to 3 years.
Basic Steps of Issuance of Import License

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9
Identify distributor in India (holding forms 20B and 21B).
Continued..
Apply for Import License using Forms 8 and 9 with rest of documents mentioned
Obtain Import License (Form 10) from CDSCO. License valid for up to 3 years, or until the Registration
Certificate expires.
You are now authorized to market your IVD products in India.

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Basic Steps of Issuance of Mfg. License
10
Phase 1
Submit Application
(Details of Manufacturing
Facility
Product Dossiers)
Audit by Drug Authorities
Approved
NO
Phase 2
Make 3 Test
Batches
Product Evaluation
(From NIB, Noida
or
NICD, New Delhi)
Approved
Generate Stability
Date
Phase 3
Apply for
Manufacturing
Licence
Audit by Drug
Officials
(Joint Inspection
by State & Central
Drug Authorities)
Approved
Licence Granted
NO
NO
(Re-
Audit)

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Time Line for Various Licenses’ Approval
11
Average time required
for license approval.
Mfg. Licence
for Non-Notified IVDs.
Mfg. Licence
for Notified IVDs
1Month
2Months
3Months
4Months
5Months
6Months
7Months
8Months
9Months
10Months
11Months
12Months
Import Licence for
Non-Notified IVDs
Import Licence for
Notified IVDs

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12
GMP Fundamentals
Manufacturing
Quality
Assurance
Quality Control
Quality Management
Documentation
Qualification and
Validation
Contract
Production and
Analysis
Complaints and
Product Recall
Self-Inspection, Quality Audits and Supplier’s
Audits and Approval
Personnel,
Training
Premises Equipment
Sanitation
and
Hygiene
Holding and
Distribution
GMP Fundamentals

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Thank You..!!!