CDSCO Registration For Oncology Medical Devices | Medical Device Registration | Corpbiz скачать в хорошем качестве

CDSCO Registration For Oncology Medical Devices | Medical Device Registration | Corpbiz

#Oncology refers to the branch of medicine concerned with the diagnostics and treatment of cancerous diseases. The term ‘medical device’ can refer to any device/apparatus/instrument as such that is used in medical practices on humans or animals, with specific intended purposes related to analysis, treatment, prevention, etc., of physiological afflictions. Several medical devices exist to aid, primarily, in diagnosing cancer patients and to map the severity of the affliction; these are referred to as Oncology #Medical Devices. Imaging technologies such as MRIs, PET Scans, ultrasounds, etc., are regularly used by oncologists to diagnose cancerous diseases and growths such as tumours. Currently, only certain medical devices notified under the Drugs & Cosmetics Act 1940 are regulated. In 2020, The #CDSCO provided a list of Oncology Medical Devices, which consisted of 31 devices and classified them based on their intended use and risk class. As of October 2022, all Medical Devices labelled under Risk Class A ( which is non measuring , non sterile ) or B will require CDSCO licensing. Importers of Oncology Medical Devices would require a licence from the CDSCO to sell their products in India. The comprehensive list is available online on the CDSCO webpage. Documents Required For CDSCO Registration For Oncology Medical Devices Following are some vital documents required for CDSCO Registration for Oncology Medical Devices: Pr-screening checklist-CISCO Registration for Oncology Medical Devices • Covering Letter • Self-attested copy of authorization letter to the person issued by the Director/Company Secretary/Partner of the Indian Agent firm • Detail Product description along with the material of construction, intended use, Product specification, product literature, package inserts along with a sample • The regulatory status of the said product in the country of origin • Regulatory certificates in respect of said product To register on the online portal- • Id Proof Details • Undertaking • Corporate Address Proof Details (Certificate of Incorporation) • Copy of the Manufacturing Licence and the Wholesale Licences( in case of import ) For Registration of devices by the manufacturer- • Name & address of the company/firm/any other entity manufacturing the medical device, along with the name & address of the manufacturing site of the medical device. • Details of the medical device. • Certificate of compliance concerning ISO 13485 accredited by National Accreditation Board for Certification Bodies/International Accreditation Forum in respect of such medical device. • Undertaking duly-signed by the manufacturer stating that the information provided by the applicant is true and authentic. For Registration of devices by the importers- • Name of the company/firm/any other entity importing the medical device. • Details of the medical device. • Specification and standards of that medical device. • Certificate of compliance concerning ISO 13485 accredited by National Accreditation Board for Certification Bodies/International Accreditation Forum in respect of such medical device. • Free sale certificate from country of origin. • Undertaking duly-signed by the importer stating that the information provided by the applicant is authentic. CDSCO Registration for Oncology Medical Devices – Procedure: 1Identify Whether a Medical Device needs to be registered: The CDSCO has provided a list of notified medical devices that require Registration under the Drugs & Cosmetics Act, 1940 and as per MDR, 2017. However, there may be any medical devices that haven’t been notified by the CDSCO, or in the case of a new medical device, the manufacturer or importer shall be required to get a NOC in such cases. 2Appoint an IAA: In the case of a Foreign Manufacturer, an Indian Authorised Agent is appointed. The Indian Authorised Agent or IAA represents the manufacturer in court & carries out all of their official business in India. 3Documentation: To Obtain a CDSCO Registration License, all required documents must be submitted to the concerned authorities. 4 Issuance of License: The manufacturer gets the Registration License after submitting the application & all the required documents to the appropriate authorities. Know more: https://corpbiz.io/learning/cdsco-reg... Phone:- 7838392800 Email:- [email protected] Want to know more about #Corpbiz​? Subscribe to our Corpbiz channel to get the latest updates, tips, and help. https://bit.ly/3w7AFJ5 Website: https://corpbiz.io​ Facebook:   / corpbizhq​   Twitter:   / corpbizhq​   Instagram:   / corpbizhq   LinkedIn:   / corpbizhq