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    Indian Manufacturing Approval
    Indian Manufacturing Approval

    Write to enquiry@i3cglobal.com

    CDSCO Medical Device Manufacturing License

    The Medical Device Industry has been changed in various ways, as per the government policies, from the last two decades, such as, Domestic driven to Import dependent, non-regulated to regulated devices, general classification to risk-based classification, under pharma domain to specifically rules for medical devices at the licensing authority level. The new set of initiatives, such as Medical Device Rules 2017 & Materiovigilance make the industry to meet the global standards for medical devices. To make India as a self-reliant in every sector, the government encourages local manufacturers through various incentives, to meet the demand in Indian healthcare system.

    cdsco manufacturing license

    The government has taken various steps to ensure that the medical devices sector is considered as significant as the other sectors. The new set of regulatory practices aims to remove the hurdles so as to prepare India to meet the Medical devices sector requirements. These new rules shall thus enhance ease of doing business and ensure availability of quality medical devices. Also, for the very first time, periodic renewal of licenses will not be required. Consequently, manufacturing and import licenses will be valid until it is suspended or cancelled. The rules also aim to promote a culture of self-compliance by manufacturers of medical devices. In addition, the manufacturing licenses for certain medical devices are granted without prior audit of the manufacturing site. In such cases, the manufacturer has to do self- certification of compliance with the essential requirements and on the basis of such certification, the license will be issued.

    Medical Device Classification

    Medical devices are classified on the basis of risk parameters, namely: —

     

    1. Low risk – Class A; Hydrophilic Wound Dressing, Latex Medical Examination Glove
    2. Low moderate risk- Class B; Nitrile Gloves, Foetal Doppler System,
    3. Moderate high risk- Class C; Negative Pressure Ventilator, Implantable Ligating Clip
    4. High risk- Class D: Flexible Ultrasound bronchoscope, Intracranial Pressure Monitor Device

    Medical Device License approving Authority

    Based on the risk classification of device, the approval authority for the manufacturing license is differs.
    Manufacturing license for Class A & Class B devices will be obtained from State Drug Control Authority, where the manufacturing unit has established.

     

    For Class C & Class D devices, the license will be issued from the CDSCO.

     

    We will assist you for the entire process by establishing the quality management system, getting the test license application, if required, submitting the application, facing the audits and also for the query response.

    Important Requirements for Medical Device Approval

    PALNT MASTER FILE

    DEVICE  MASTER FILE

    QUALITY MANAGEMENT SYSTEM

    TECHNICAL STAFF

    As per Part III, Appendix I of India MDR, the plant master file / site master file should contain information related to personnel, premises & facilities, equipment, sanitation, production, storage, quality assurance and documentation, handling of complaints, internal audits and contract activities

    ……………………………………………………………………………………………………………………………………………..

    As per Part III, Appendix II of India MDR, the device master file should contain Device description, Design and Manufacturing process, Design verification & validation reports, Essential Principles checklist, Risk analysis report, Clinical evaluation, Biocompatibility reports, stability data, sterilization validation reports and PMS data

    ……………………………………………………………………………………………………………………………………………..

    The manufacturing site should comply with the requirements of the Quality Management System as specified under the Fifth Schedule of India MDR

    ……………………………………………………………………………………………………………………………………………..

    The manufacturer should appoint competent technical staff under whose direction and supervision the manufacturing activity of a medical device shall be undertaken, and such staff should possess desired educational qualification and experience

    FEES ( CDSCO )

     

    1. Manufacturing license or loan license to manufacture Class A or Class B medical device for one site is 5000 INR, and for each distinct medical device 500 INR

     

    2. Manufacturing license or loan license to manufacture Class C or Class D medical device for one site is 50000 INR, and for each distinct medical device 1000 INR

     

    Timeline:

     

    For Class A and Class B, it will take 4-6 months to get the manufacturing license. For Class C and Class D, it will take 5-7 months. Please consider the timelines for reference purpose only.

     

    Validity:

     

    A license or loan license issued in Form MD-5, Form MD-6, Form MD-9 or Form MD10 shall remain valid in perpetuity, for the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority or the Central Licensing Authority

     

    Forms:

     

     

    Form MD-3: Application for Grant of License to Manufacture for Sale and Distribution of Class A or Class B medical device
    Form MD-5: License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device
    Form MD-4: Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class A or Class B medical device
    Form MD-6: Loan License to Manufacture for Sale or for Distribution of Class A or Class B medical device
    Form MD-7: Application for Grant of License to Manufacture for Sale or for Distribution of Class C or Class D
    Form MD-9: License to Manufacture for Sale or for Distribution of Class C or Class D
    Form MD-8: Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class C or Class D
    Form MD-10: Loan License to Manufacture for Sale or for Distribution of Class C or Class D medical device

    MEDICAL DEVICE TESTING

     

    Medical Devices and IVDs must be evaluated, before releasing into the market, as per the Medical Device Rules. Some of the devices need to be evaluated for each production batch, based on its characteristics. During the design and development there are certain type of tests should be performed to evaluate the safety and performance of the device. The medical device should conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. Where no relevant Standard of any medical device has been laid down, such device should conform to the standard laid down by the International Organization for Standardization (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia standards. In case of the standards which have not been specified above, the device should conform to the validated manufacturer’s standards.

     

    We will support you to prepare the protocols and applications as per the testing laboratory requirements and coordinate with you during the testing process by selecting the laboratory for your device testing, as per the requirements. Our support will enhance your processes to deliver the batch into the market as per your expected timelines.