Device registration ppt

WELCOME Accredited Consultants Pvt.

Ltd.

D-29, Ist Floor, Acharya Niketan,

Mayur Vihar Phase I, Delhi 110091

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 ?

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.


Hierarchy of Medical Device Regulatory entities in India


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)

Medical Devices Regulated In India

Only Medical Devices that are Notified under Drugs and

Cosmetics Acts are Regulated in India.


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


DEVICE REGISTRATION

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.



FLOW CHART FOR REGISTRATION

Legal Documents Regulatory documents Technical Documents Form 40 POA, DI & DII Undertakings Labels/Inserts

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)


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


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


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 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 INSERTS

Product labels should show the address of Manufacturer.

Product inserts should describe the brief description of the product and its intended use.


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).


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


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.


OUR HEARTFUL THANKS

WE BELIEVE OUR CLIENTS ARE OUR KINGS!!!

Date post:	23-Aug-2014
Category:	Healthcare
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Device registration ppt

Healthcare