Device Registration

WELCOMEWELCOME
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LtdLtd..

What is a Medical Device ?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.
Accredited Consultants Pvt. Ltd.

Who is the Regulatory Body ?Who is the Regulatory Body ?
The Drugs Controller General (India) of Central
Drugs Standard Control Organisation (CDSCO) is the
Regulatory Authority That:
Governs the Import,
manufacture,
sale and distribution of Medical Devices under the
Drug & Cosmetic Act 1940 & Rules.

Hierarchy of Medical DeviceHierarchy of Medical Device
Regulatory entities in IndiaRegulatory entities in India
Ministry of Health and Family Welfare
Drug Cont r oller General of I ndia -
DCG(I )
Drug Controller General of India - DCG(I)
Central Drugs Standard Control Organisation
(CDSCO - Medical Devices Division)

Medical Devices Regulated In IndiaMedical Devices Regulated In India
Only Medical Devices that are
Notified under Drugs and Cosmetics
Acts are Regulated in India.

Notified Medical DevicesNotified 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.

DRUG REGULATION SYSTEM IN INDIADRUG REGULATION SYSTEM IN INDIA
Drug Controller General of India is the head of
Central Drug Standard Control Organisation , 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.

FLOW CHART FOR REGISTRATIONFLOW CHART FOR REGISTRATION
Legal Documents Regulatory documents Technical Documents
Form 40 POA, DI & DII Undertakings
Labels/Inserts

LEGAL DOCUMENTSLEGAL 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)

REGULATORY DOCUMENTSREGULATORY 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

Technical DocumentsTechnical Documents
I. Plant Master FileI. 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

 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

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

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)

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

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

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

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

II. Device Master FileII. 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

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)

III. LABELS AND INSERTSIII. 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.

PROCESSING PROCEDUREPROCESSING 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.
During this period clarification if any, are
required by them are answered.
Thereafter we get the Renewed Registration
Certificate (RC).

IMPORT PROCESSINGIMPORT 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

TIME LINE FOR IMPORT LICENSETIME 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 1,000.00
[INR One Thousand only] for First product then Rs 100.00
for each additional product is
required.

Contact DetailsContact Details
Address:
Accredited Consultants
Private Limited,
D-29, First Floor,
Acharya Niketan,
Mayur Vihar Phase-I,
Delhi-110091.
Telephones:
Landline: 011-22758204,
Mobile: +91-9310040434,
+91-9266665201
Fax: 011-22758994
Email:
bhatbio@gmail.com
info@acplgroupindia.com
info@acplgroupindia.co.in
Websites:
www.apclgroupindia.co.in
www.apclgroupindia.com

Device Registration

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