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    Importer Registration Of Medical Devices Under CDSCO

    Importer Registration Of Medical Devices Under CDSCO

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    Background

    Every importer and a manufacturer of medical devices in India must fulfil the legal compliances mentioned by Central Drug Standard Control Organisation (CDSCO), part of the Ministry of Health and Family Welfare.

    Medical devices are regulated under Medical Device Regulations, 2017 which are enacted by the central government using the powers conferred by Drugs and Cosmetics Act, 1940 which regulates the import, manufacture and distribution of drugs in India.

    The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.

    Classification Of Medical Devices

    Under the Medical device and In-vitro device regulations, the Health Ministry Of India has divided medical devices into following four Different risk classes:

    CLASS A
    LOW RISK

    CLASS B
    LOW TO MODERATE RISK

    CLASS A
    LOW RISK

    CLASS D HIGH RISK

    Two Categories Of Medical Devices

    The medical device industry from the perspective of regulatory is divided into two broad categories:

    Medical Devices

    In-Vitro medical devices

    These devices are the one which are used for The Diagnostic Purpose such as urine test strips, cholesterol self testing kits, pregnancy test kits and many more.

    List Of Documents Required For Import Registration?

    • Duly apostilled/notarized copy of Free Sale Certificate/Marketing Authorization of the product from National Regulatory Authority of country of origin.

    • Duly apostilled/notarized copy of Free Sale Certificate Marketing Authorization of the product from National Regulatory Authority of any of the following countries viz USA, EU, Canada, Japan, Australia.

    • Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within the last 3 years

    • Notarized copy of Certificate supporting quality management system (ISO: 13485)- It’s available, just need notarized copy

    • Notarized Full quality Assurance Certificate/CE type examination Certificate/CE product quality assurance- It’s available, just need notarized copy

    • Notarized CE design Certificate

    • Notarized Declaration of conformity

    • Plant Master file from the Manufacturer as specified in Appendix 1 of Fourth Schedule of Medical Devices Rules

    • Device Master file from the Manufacturer as specified in Appendix II of Fourth Schedule of Medical Devices Rules.- Technical file available, need all appendix mentioned in technical file to prepare DMF

    • Label- importer name and address,Lot no.,net quantity,mfg. date

    • Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority

    • Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority

    • Copy of Selling & Distribution licence of

    Government Fees For Importer Registration

    Validity for Import Licence of Medical Device

    Medical device licence is valid for 5 years (Class A, B, C & D) .when the import licence expires, Importer has to renew his/her licence. For renewal there is no need for all documents, only old import licence and fee challan are required.

    Frequently Asked Questions

    Any individual, business, or other organisation, who has obtained valid importer registration for the medical devices to be imported is allowed.
    In such cases, the higher class of medical device will be considered
    The list of authorised notified bodies under (CDSCO) is available on the CDSCo website. To receive the latest copy of the notified bodies, click here (Name, M.No., Email, Message = Please send me Latest notified bodies list.

    Notified body under CDSCo shall be competent to carry out and audit of the manufacturing site to ensure the conformity of the prescribed standards of Quality Management System (QMS) and other applicable tender advised by state licensing authority(SLA).

    According to the Medical Device Rule 2017, National Board for certification bodies (NABCB) shall lay down the conformity assessment activities for accreditation of Notified bodies prior to registration with CDSCO.
    Devices such as sedentary pads, Tampons Etc. were removed from the list at government does not want the people to have compliance difficulties on routine items.

    For the application of import or manufacturing licence, applicants group all medical devices in accordance with government guidelines. In case of difference of intended use, product specification and principle technology of the medical devices, separate fees need to be submitted.

    PMS is the responsibility of a licensed holder or authorised agent.

    Import licences are valid for five years and are renewed through a simple administrative process.

    ISO 13485 Certification is required to certify the quality system of the legal manufacturing facilities as a part of the Plant Master File (PMF) application product.

    No its not mandatory, Please watch this video for detailed information: https://youtu.be/Ghv-83ksPlU

    Exemption Of Class A Medical Devices From Obtaining MD-15 (Latest Notification Of Class A Non Sterile & Non Measuring)

    As per the Final notification by cdsco , if one wantS to import a medical device which is classA non sterile and non measuring now no longer needs a registration under MD-15.

    They can proceed with a voluntary registration number which can be obtained with the help of the ELT Medilaw Team.

    Please visit this link for any information…