Device registration ppt


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To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences

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Device registration ppt

  1. 1. WELCOME Accredited Consultants Pvt. Ltd. D-29, Ist Floor, Acharya Niketan, Mayur Vihar Phase I, Delhi 110091
  2. 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. Accredited Consultants Pvt Ltd
  3. 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. Accredited Consultants Pvt Ltd
  4. 4. 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)
  5. 5. Medical Devices Regulated In India  Only Medical Devices that are Notified under Drugs and Cosmetics Acts are Regulated in India. Accredited Consultants Pvt Ltd
  6. 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
  8. 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. Accredited Consultants Pvt Ltd
  9. 9. Accredited Consultants Pvt Ltd FLOW CHART FOR REGISTRATION Legal Documents Regulatory documents Technical Documents Form 40 POA, DI & DII Undertakings Labels/Inserts
  10. 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) Accredited Consultants Pvt Ltd
  11. 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 Accredited Consultants Pvt Ltd
  12. 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 Accredited Consultants Pvt Ltd
  13. 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 Accredited Consultants Pvt Ltd
  14. 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 Accredited Consultants Pvt Ltd
  15. 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) Accredited Consultants Pvt Ltd
  16. 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 Accredited Consultants Pvt Ltd
  17. 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 Accredited Consultants Pvt Ltd
  18. 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 Accredited Consultants Pvt Ltd
  19. 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 Accredited Consultants Pvt Ltd
  20. 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 Accredited Consultants Pvt Ltd
  21. 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) Accredited Consultants Pvt Ltd
  22. 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. Accredited Consultants Pvt Ltd
  23. 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). Accredited Consultants Pvt Ltd
  24. 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 Accredited Consultants Pvt Ltd
  25. 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. Accredited Consultants Pvt Ltd