Overview of India IVD Regulations

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

FOR INTERNAL USE ONLY. NOT FOR PRINT OR DISTRIBUTION2

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.


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.


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


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


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


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


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


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


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.


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)


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

on

th

2 M

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ths

3 M

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4 M

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5 M

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6 M

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7 M

on

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8 M

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9 M

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10

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11 M

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12

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Import Licence for Non-Notified IVDs

Import Licence for Notified IVDs


GMP Fundamentals

Manufacturing

Quality Management

Documentation

Self-Inspection, Quality Audits and Supplier’s Audits and Approval

Personnel, Training

GMP Fundamentals

FOR INTERNAL USE ONLY. NOT FOR PRINT OR DISTRIBUTIONFOR INTERNAL USE ONLY. NOT FOR PRINT OR DISTRIBUTION

Thank You..!!!

Overview of India IVD Regulations

Healthcare

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