Device registration ppt
-
Upload
prasad-bhat -
Category
Healthcare
-
view
286 -
download
1
description
Transcript of 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.
Accredited Consultants Pvt Ltd
Hierarchy of Medical Device Regulatory entities in India
Accredited Consultants Pvt Ltd
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.
Accredited Consultants Pvt Ltd
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
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.
Accredited Consultants Pvt Ltd
Accredited Consultants Pvt Ltd
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)
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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)
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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)
Accredited Consultants Pvt Ltd
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.
Accredited Consultants Pvt Ltd
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).
Accredited Consultants Pvt Ltd
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
Accredited Consultants Pvt Ltd
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.
Accredited Consultants Pvt Ltd
OUR HEARTFUL THANKS
WE BELIEVE OUR CLIENTS ARE OUR KINGS!!!