Download - Overview of India IVD Regulations
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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.
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IndiaThe 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.
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CDSCO Organization Chart and their Function
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.
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
Notified IVDs
1.IVD kits of HIV2.IVD kits of HCV
3.IVD kits of HBsAg
Non-Notified IVDs
Semi-critical
1.Cancer Markers2.Dengue
3.Chikungunya4.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
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)
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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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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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
Phase 1
Submit Application(Details of Manufacturing
FacilityProduct Dossiers)
Audit by Drug Authorities
Approved
NO
Phase 2
Make 3 Test Batches
Product Evaluation(From NIB, Noida
orNICD, 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
Average time required for license approval.
Mfg. Licence for Non-Notified IVDs.
Mfg. Licence for Notified IVDs
1 M
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2 M
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9 M
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11 M
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Import Licence for Non-Notified IVDs
Import Licence for Notified IVDs
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GMP Fundamentals
Manufacturing
Quality Management
Documentation
Self-Inspection, Quality Audits and Supplier’s Audits and Approval
Personnel, Training
GMP Fundamentals
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Thank You..!!!