| \n Class D\n <\/td> | \n High Risk\n <\/td><\/tr><\/tbody><\/table>\n\n\n\n Different authority issues licences to manufacturers or importers. Here\nis the list of such licensing authorities with the medical devices:<\/p>\n\n\n\n\n \n Medical\n device classes<\/strong>\n <\/td>\n Licensing\n authority<\/strong>\n <\/td><\/tr>\n Class A<\/strong>\n (manufacture)<\/strong>\n <\/td>| \n State Licensing Authority\n <\/td><\/tr> | \n Class B<\/strong>\n (manufacture)<\/strong>\n <\/td>| \n State Licensing Authority\n <\/td><\/tr> | \n Class C and D<\/strong>\n (manufacture) <\/strong>\n <\/td>| \n Drugs Controller General of India\n <\/td><\/tr> | \n Class A and B<\/strong>\n (import)<\/strong>\n <\/td>| \n Drugs Controller General of India\n <\/td><\/tr> | \n Class C and D<\/strong>\n (import)<\/strong>\n <\/td>\n Drugs Controller General of India\n <\/td><\/tr><\/tbody><\/table>\n\n\n\n<\/span>Changes\nin Amended Rules related to Medical Device Classes<\/span><\/h2>\n\n\n\nA new chapter IIIA\nwith the title Registration of Certain Medical Devices with Sl. No. 7 in the\nEight Schedule has been added by the amendment. Changes made by the Medical\nDevice (Amendment) Rules, 2020 are explained as follows:<\/p>\n\n\n\n Requirement of registration <\/h3>\n\n\n\nManufacturers or\nimporters of all classes of medical devices require mandatory registration of\ntheir medical devices with the DCGI, Drugs Controller General of India. If a\nmanufacturer or importer fails to obtain such registration, then it will not be\nable to sell its medical devices in the Indian market. No time limit is\nprescribed for processing an application for registration by DCGI. <\/p>\n\n\n\n The information\nthat is required to be submitted to obtain registration is as follows:<\/p>\n\n\n\n - Name of company or other entity<\/li>
- Details of manufacturing site (for medical devices manufactured in India)<\/li>
- Specification and standards of medical devices (for imported medical devices)<\/li>
- Details of Medical Devices<\/li>
- Certificate of compliance concerning ISO 13485\u00a0<\/li>
- Free Sale Certificate from origin country (in case of imported devices only)<\/li>
- Undertaking<\/li><\/ul>\n\n\n\n
Registration is\ncompleted upon obtaining the Registration Number. Every manufacturer and\nimporter must display the registration number on its label. <\/p>\n\n\n\n Once a\nmanufacturer or importer registers its medical devices, it has to conform to\nthe Quality Management System (QMS) strictly. If DCGI finds any non-fulfilment\nof QMS, it has all its right to suspend or cancel the registration.<\/p>\n\n\n\n Requirement of License<\/h3>\n\n\n\nManufacturers and\nimporters of newly notified medical device classes must obtain a license under\nMedical Device Rules before the prescribed deadline. <\/p>\n\n\n\n Penalty<\/h3>\n\n\n\nThe Central Licensing\nAuthority (CLA) verifies documents and investigates the quality or safety of\nmedical device classes related to their failure or complaint. In case the\nregistered manufacturer or importer fails to comply with any provision of\nMedical Device (Amendment) Rules, 2020. CLA first gives an opportunity to show\ncause, why an order for cancellation of its registration should not be passed,\nin writing stating the reason thereof, cancels or suspends (for such period as\nit thinks fit) the registration, either wholly or in respect of any medical\ndevice to which the failure relates. <\/p>\n\n\n\n Relaxation <\/h3>\n\n\n\nThe Indian\nGovernment has provided extra time to the medical device industry to transition\ninto the regulatory framework and to obtain the required ISO 13845\nCertification. It has also relaxed the requirement of obtaining registration\nand licenses for all medical device classes for the following periods:<\/p>\n\n\n\n - Voluntary registration to manufacture, import, distribute or sell newly notified medical devices: 1st April 2020 to 1st October 2021.\u00a0\u00a0<\/li>
- Mandatory registration required to import, manufacture, sell or distribute medical devices: after 1st October 2021<\/li>
- Licenses required to manufacture, import, distribute or sell medical device class A (low risk) and B (medium risk): Before 11th August 2022<\/li>
- Licenses required to manufacture, import, distribute or sell medical device class C (moderate high risk) and D (high risk): Before 11th August 2023.<\/li><\/ul>\n\n\n\n
If an importer or\nmanufacturer of a medical device fails to obtain the required registration or\nlicense before the deadline. In that case, it must stop importing or\nmanufacturing the said medical device until the said registration or license is\nobtained. As per Medical Device Rules, manufacturing or selling any medical\ndevice without a valid license or registration attracts criminal prosecution,\nincluding imprisonment for not less than three years and which may be extended\nto 5 years and a fine of Rs. 1 Lakh or three times of the value of drugs\nconfiscated. <\/p>\n\n\n\n Exemption<\/h3>\n\n\n\nExemption for 37\nmedical device classes or categories regulated or proposed before 111th\nFebruary 2020, i.e., the date of the Medical Device Rules Amendment, are not to\nbe affected by this amendment and so do not require to obtain\nregistration. <\/p>\n\n\n\n
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