The document outlines the regulatory framework for medical devices in India, detailing the definition of medical devices, the role of the Drugs Controller General of India, and the regulatory hierarchy. It provides information on the registration and import processes, including required fees and documentation for manufacturers and Indian agents. Various types of medical devices that require notification under the Drugs and Cosmetics Act are also listed.

1. WELCOME
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2. What is a Medical Device ?
Devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of diseases or disorders in
human beings or animals.
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3. Who is the Regulatory Body ?
 The Drugs Controller General (India) of Central Drugs
Standard Control Organization (CDSCO) is the Regulatory
Authority that Governs the Import, manufacture, sale and
distribution of Medical Devices under the Drug & Cosmetic
Act 1940 & Rules.
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4. Hierarchy of Medical Device
Regulatory entities in India
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Ministry of Health and Family Welfare
Drug Controller General of India - DCG(I)
Drug Controller General of India - DCG(I)
Central Drugs Standard Control Organisation
(CDSCO - Medical Devices Division)

5. Medical Devices Regulated In
India
 Only Medical Devices that are Notified under Drugs and
Cosmetics Acts are Regulated in India.
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6. Notified Medical Devices
 Disposable Hypodermic Syringes
 Disposable Hypodermic Needles
 Disposable Perfusion sets
 In-Vitro Diagnostic Devices for HIV, HbsAg and HCV
 Cardiac Stents
 Drug Eluting Stents
 Catheters
 Intra Ocular Lenses
 I.V. Cannulae
 Bone Cements
 Heart Valves
 Scalp Vein Set
 Orthopaedic Implants
 Internal Prosthetic Replacements Accredited Consultants Pvt Ltd

7. DEVICE
REGISTRATION

8. DRUG REGULATION SYSTEM IN
INDIA
Drug Controller General of India is the head of Central Drug
Standard Control Organization , which regulates Devices &
Drugs in India.
TR Challan: Fees of 1500 USD is required for site registration
and 1000 USD for registration of each product.
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9. Accredited Consultants Pvt Ltd
FLOW CHART FOR REGISTRATION
Legal Documents Regulatory documents Technical Documents
Form 40 POA, DI & DII Undertakings Labels/Inserts

10. LEGAL DOCUMENTS
Documents To be submitted by Indian agent
 Form 40- It should be signed and stamped by Indian agent.
Documents To be submitted by Manufacturer
 POA- Power of attorney should be Appostilised or
Consularized from Indian embassy of country of origin, and
should be co-jointly signed by both the parties i.e
Manufacturer and Indian Agent.
 Schedule DI & DII- They should be signed and stamped by
Manufacturer. (Need not to be notarized)
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11. REGULATORY DOCUMENTS
 Notarized Plant Registration Certificate
 Notarized Manufacturing & Marketing License
 Notarized Free Sale Certificate
 Notarized EU medical device directive (CE Certificate).
 CE Declaration of Conformity Notarized
 Notarized CE Design Certificate
 Notarized CE full quality Assurance
 GMP Certificate Notarized
 ISO Certificate Notarized
 Whole Sale License (20B & 21B) of Indian Agent
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12. Technical Documents
I. Plant Master File
1.GENERAL INFORMATION
 Brief information on the site (including name and
address), relation to other sites
 Manufacturing activities as licensed by the Competent
Authorities
 Any other operations carried out on the site
 Name and exact address of the site, including
telephone, fax numbers, web site URL and e-mail
address
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13.  Type of medical devices handled on the site and
information about specifically toxic or hazardous
substances handled, mentioning the way they are handled
and precautions taken
 Short description of the site (size, location and immediate
environment and other activities on the site
 Number of employees engaged in Production, Quality
Control, warehousing, and distribution
 Use of outside scientific, analytical or other technical
assistance in relation to the design, manufacture and
testing
 Short description of the quality management system of the
company
 Devices details registered with foreign countries
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14. 2.PERSONNEL
 Organization chart showing the arrangements for key
personnel
 Qualifications, experience and responsibilities of key
personnel
 Outline of arrangements for basic and in-service training
and how records are maintained
 Health requirements for personnel engaged in
production
 Personnel hygiene requirements, including clothing
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15. 3. PREMISES AND FACILITIES
 Layout of premises with indication of scale
 Nature of construction, finishes/fixtures and fittings
 Brief description of ventilation systems. More details
should be given for critical areas with potential risks of
airborne contamination (including schematic drawings of
the systems). Classification of the rooms used for the
manufacture of sterile products should be mentioned
 Special areas for the handling of highly toxic, hazardous
and sensitizing materials
 Brief description of water systems (schematic drawings
of the systems are desirable) including sanitation
 Maintenance (description of planned preventive
maintenance programs for premises and recording
system)
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16. 4. EQUIPMENT
 Brief description of major production and quality
control laboratories equipment (a list of the equipment
is required)
 Maintenance (description of planned preventive
maintenance programs and recording system
 Qualification and calibration, including the recording
system. Arrangements for computerized systems
validation.
5. SANITATION
 Availability of written specifications and procedures for
cleaning the manufacturing areas and equipments
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17. 6. PRODUCTION
 Brief description of production operations using,
wherever possible, flow sheets and charts specifying
important parameters
 Arrangements for the handling of starting materials,
packaging materials, bulk and finished products,
including sampling, quarantine, release and storage.
 Arrangements for reprocessing or rework
 Arrangements for the handling of rejected materials
and products
 Brief description of general policy for process
validation
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18. 7. QUALITY CONTROLS
 Description of the Quality Control system and of the
activities of the Quality Control Department. Procedures
for the release of finished products
8. STORAGE
 Policy on the storage of medical device
9. DOCUMENTATION
 Arrangements for the preparation, revision and
distribution of necessary documentation, including
storage of master documents
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19. 10. MEDICAL DEVICE COMPLAINTS AND FIELD
SAFETY CORRECTIVE ACTION
 Arrangements for the handling of complaints
 Arrangements for the handling of field safety corrective
action
11. SELF INSPECTION
 Short Description of the internal audit system
12. CONTRACT ACTIVITIES
 Description of the way in which the compliance of the
contract acceptor is assessed
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20. II. Device master file
1. Executive summary
2. Device Description and product specification,
including variants and accessories
 Device Description
 Product Specification
 Reference to predicate and/or previous generation
of the device
3. Labeling
4. Design and Manufacturing information
 Device Design
 Manufacturing Processes
5. Essential Principal Checklist
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21. 6. Risk Analysis and control Summary
7. Product Verification and validation
 General
 Biocompatibility
 Medicinal Substance
 Biological safety
 Sterilization
 Software Verification and validation
 Animal Studies
 Shelf life/Stability Data
 Clinical Evidence
 Post Marketing Surveillance DATA (Vigilance reporting)
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22. III. LABELS AND INSERTS
 Product labels should show the address of Manufacturer.
 Product inserts should describe the brief description of
the product and its intended use.
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23. PROCESSING PROCEDURE
After ensuring all documents correctly as per the
requirements of FDA, they are submitted. It generally takes
about 4-5 months to scrutinize these documents by Technical
Data Associates/Drug inspectors of CDSCO and during this
period clarification if any, are required by them are answered
and thereafter we get the Renewed Registration Certificate
(RC).
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24. IMPORT PROCESSING
After getting the registration certificate from CDSCO, the
Indian agent is now import the products from the
manufacturer. Following documents are further required to
get Form 10 (Import license).
 Form 8
 TR Challan- (Rs 1000 for Ist product then Rs 100 for each
 additional product)
 Form 9
 Copy of Wholesale License (Indian agent)-Notarized
 Copy of Registration Certificate-Notarized
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25. TIME LINE FOR IMPORT LICENSE
The Importer (Indian agent) is not authorized to import the
products from foreign manufacturer unless he obtains Import
license (Form 10) form CDSCO.
It generally takes about one month to scrutinize these
documents by Technical Data Associates/Drug inspectors of
CDSCO and during this period clarification if any, are required
by them are answered and thereafter the importer gets the
Import license.
For Import license application TR Challan of Rs 1000 for Ist
product then Rs 100 for each additional product is required.
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26. OUR HEARTFUL THANKS
WE BELIEVE OUR CLIENTS ARE OUR KINGS!!!