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    • Gazette calls for...

    Gazette calls for registrations of medical devices, details

    Farhat NasimWritten by Farhat Nasim Published On 2020-02-13T11:30:38+05:30  |  Updated On 13 Feb 2020 12:58 PM IST
    Gazette calls for registrations of medical devices, details

    New Delhi: Through a recent notification, the Union Health Ministry has mandated the registration of certain medical devices with the apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) effective from April 1, 2020.

    In exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board has amended the Medical Devices Rules, 2017.

    Prior to the amendment, a draft was circulated in the public domain seeking objections and suggestions. Accordingly, after receiving and considering the suggestions given by the stakeholders, the Central Government has amended the said rules. The rules may be called the Medical Devices (Amendment) Rules, 2020.

    As per the amendment, in the Medical Devices Rules, 2017 (hereinafter to be referred to as said rules), after CHAPTER III, a CHAPTER IIIA will be inserted. This chapter will be called- CHAPTER IIIA REGISTRATION OF CERTAIN MEDICAL DEVICES. The details of the chapter read;

    19A. (1) This Chapter shall be applicable to all devices notified under clause (b) of section 3 of the Act except the medical devices and devices specified in the Annexure of Eighth Schedule of these rules.

    (2) The Medical devices referred to in sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose:

    Provided that registration under this Chapter shall be on a voluntary basis for a period of eighteen months from the commencement of this Chapter thereafter it shall be mandatory.

    Also Read: All Medical Devices To Be Classified As DRUGS, Details

    19B. (1) The manufacturer of a medical device shall upload the information specified in sub-rule (2) relating to that medical device for registration on the "Online System for Medical Devices" established by the Central Drugs Standard Control Organisation for this purpose

    (2) The manufacturer shall upload, -

    (i) name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device,

    (ii) Details of medical device

    Generic Name

    Model No.

    Intended Use

    Class of Medical device

    Material of Construction

    Dimension (if any)

    Shelf Life

    Sterile or Non Sterile

    Brand Name (if registered under the Trade Marks Act, 1999)

    (iii) certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.

    (iv) undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.

    19C. After furnishing of the above information on the "Online System for Medical Devices" established by Central Drugs Standard Control Organisation for this purpose by the applicant's, a registration number will be generated. The manufacturer shall mention the registration number on the label of the medical device.

    19D. (1) Any person who imports any medical device referred in rule 19A shall upload the following information relating to that medical device for registration on the "Online System for Medical Devices" established by the Central Drugs Standard Control Organisation for this purpose.

    (2) The importer shall upload, -

    (i) name of the company or firm or any other entity importing the medical device and specification and standards of that medical device,

    (ii) Details of medical device

    Generic Name

    Model No.

    Intended Use

    Class of Medical device

    Material of Construction

    Dimension (if any)

    Shelf Life

    Sterile or Non Sterile

    Brand Name (if registered under the Trade Marks Act, 1999)

    (iii) certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.

    (iv) Free sale certificate from country of origin.

    (v) undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.

    19E. After furnishing of the above information on the "Online System for Medical Devices" established by the Central Drugs Standard Control Organisation for this purpose by the applicant's, registration number will be generated. The importer shall mention the registration number on the label of the medical device.

    19F. Central Licensing Authority may verify the documents at any point of time and investigate quality or safety-related failure or complaints. The Central Licensing Authority may, after giving the registrant an opportunity to show cause as to why such an order should not be passed, by an order in writing stating the reasons therefor, cancel the registration number or suspend it for such period as the Central Licensing Authority thinks fit either wholly or in respect of any of the medical devices to which it relates if, in its opinion, the registrant has failed to comply with any provision of these rules.

    3. In the said rules, in the Eighth Schedule, in the table relating to exemptions, after S.N. 6, the following entry and Annexure shall be inserted, namely:―

    7

    All medical devices except those specified in the Annexure of Eighth Schedule.

    All the provisions of these rules subject to the condition that such medical devices shall be registered under CHAPTER IIIA of these rules:

    Provided that such exemption shall cease after a period of thirty months for low risk - Class A and low moderate risk - Class B and after a period of forty-two months for

    moderate high risk – Class C and high risk – Class D devices, respectively from the date of this notification.

    Annexure (See rule 19A)

    S. No.

    Name of the device

    1.

    Disposable Hypodermic Syringes

    2.

    Disposable Hypodermic Needles

    3.

    Disposable Perfusion Sets

    4.

    Substances used for in vitro diagnosis including Blood Grouping Sera

    5.

    Cardiac Stents

    6.

    Drug-Eluting Stents

    7.

    Catheters

    8.

    Intra Ocular Lenses

    9.

    I.V. Cannulae

    10.

    Bone Cement

    11.

    Heart Valves

    12.

    Scalp Vein Set

    13.

    Orthopedic Implants

    14.

    Internal Prosthetic Replacements

    15.

    Ablation Devices

    16.

    Ligatures, Sutures and Staplers

    17.

    Intra-Uterine Devices (Cu-T)

    18.

    Condoms

    19.

    Tubal Rings

    20.

    Surgical Dressings

    21.

    Umbilical tapes

    22.

    Blood/Blood Component Bags

    23.

    Organ Preservative Solution*

    24.

    Nebulizer (effective from 1 Jan.2021)

    25.

    Blood Pressure Monitoring Device(effective from 1 Jan.2021)

    For more details click on the link below:

    https://business.medicaldialogues.in/pdf_upload/pdf_upload-124204.pdf
    medical devicesmedical devices registrationcdscodrugshealth ministry

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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