1 / 11

The Complete Guide to CDSCO Medical Device Registration | RSI

Introducing medical devices in India requires strict regulation and stringent conformity assessment processes. Read our blog to learn about the requirements and steps involved in registering a medical device under CDSCO.

Regulatory
Download Presentation

The Complete Guide to CDSCO Medical Device Registration | RSI

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The Indian healthcare sector is rapidly expanding and is expected to reach $280 billion by 2025. The medical device market in India is one of the top twenty in the world. It currently has an estimated value of $11 billion, and by 2025, it is anticipated to grow astoundingly. India does not manufacture many medical devices on its own and still imports roughly 70% of its medical devices. Medical device manufacturing and monitoring are highly regulated activities. Previously, there were no specific medical device regulations in India, and devices were governed by the Drugs and Cosmetics Act of 1940. To fill this void, the Central Drug Standard Control Organization issued the Indian Medical Device Rules, 2017, which are the new medical device regulations in India. The Complete Guide to CDSCO Medical Device Registration Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  2. The Central Drugs Standard Control Organization (CDSCO), is the National Regulatory Authority (NRA) of India and reports to the Ministry of Health & Family Welfare's Directorate General of Health Services. What is CDSCO? Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  3. CDSCO is responsible for the approval of New Drugs/Medical Devices/Cosmetics, the Conduct of Clinical Trials, laying down the necessary standards, control of the quality of imported Drugs/Medical Devices/Cosmetics in the country, and coordination of the activities of the State Drug Control Organizations. CDSCO registration is necessary, in the case of:*Clinical trial and new drug approval*Licenses for imports of medical devices*Manufacturing medical devices*Vaccines, certain medical devices, and blood banks*Changes to the laws governing cosmetics and medications, as well as *any related rules*Participation in GMP certification programs run by the WHO*Issuing personal licenses, export NOCs, and test licenses Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  4. Medical devices are manufactured in a highly regulated environment and must adhere to strict regulatory requirements and guidelines because they are concerned with the health and safety of the patients. There has been a lot of activity recently in the Indian regulatory system for medical devices. The MDR, which was published in January 2017 and went into effect in January 2018 followed by the “Medical Devices (Amendment) Rules, 2020" published in February 2020 and went into effect in April 2020. The MDR (amendment) 2020 and related notification aimed to cover all medical devices being manufactured/imported and defined the steps for transiting to the new licensing regime. The definition, thus adopted, is closely aligned with the existing definition for medical devices as per Europe and Singapore regulations. The new CDSCO Medical Device Registration in India Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  5. Risk classification of Medical Devices Medical devices are generally classified according to their risks; the actual risk-based classification of the medical device is determined by its intended use and purpose. The new system has established four classes (Class A, B, C, and D), with Class A and B devices posing the lowest risk and Class C and D devices posing the highest risk to patients. For example- A (Low Risk)- Absorbent cotton wools, alcohol swabs, etc. B (Low-Moderate Risk)- Blood Pressure monitoring device, thermometer, disinfectants, etc. C (Moderate-High Risk)- Implants, hemodialysis catheter, etc. D (High Risk)- Heart valve, Angiographic guide wire, etc. Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  6. Who can apply for medical device registration under CDSCO? • CDSCO guidelines state that the following parties can register medical devices under CDSCO- • The manufacturer who has a registered office in India; • The authorized representative of the manufacturer; • The manufacturer's subsidiary; • Importer; • Domestic manufacturer Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  7. What are the requirements for granting a Medical Device Import License? Medical devices entering India must comply with the CDSCO's Indian Medical Device Regulation. CDSCO has established a comprehensive procedure for issuing licenses for medical devices imported into the country. This procedure is followed when medical devices are imported into India from other countries. They must, however, be classified according to the CDSCO notified devices list. The Central Drugs Standard Control Organization has prescribed the following forms for importers to obtain a medical device import license. For existing products In general, for an importer who wishes to obtain a medical device import license for pre-existing goods, CDSCO has prescribed “Application Form: MD -14” and the authorization to import is received in “Form: MD -15”. These forms are for all risk categories from A to D. (Some medical devices may also require a Compulsory Registration prior to obtaining the Import License). Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  8. New devices In the event that an importer wishes to obtain an import license for new medical devices for which predicates do not exist, CDSCO has prescribed “Application Form: MD -26” and the approval is received vide “Permit Form: MD -27” These forms are for all medical devices that fall under the categories from A to D. How to obtain a CDSCO medical device import license? The Ministry of Health and Family Welfare proposed an amendment to the Medical Device Registration Act in 2020 that required all importers and manufacturers of medical devices—aside from the 37 categories of medical devices previously notified—to register with the Central Licensing Authority through a designated portal made possible by the CDSCO. Currently, in order to register a medical device under the CDSCO regime, the following steps must be taken- The Importer or Manufacturer or their agent in India must submit an application for the CDSCO Medical Device Import License about the facilities & devices manufactured by the Manufacturer and intended for import into India as per following steps: Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  9. Step 1: Indian agents register themselves on the SUGAM online portal. • Step 2: Fees are to be paid online as prescribed by CDSCO for the manufacturing site and the proposed devices. • Step 3: Application to be submitted online in Form MD-14 along with the following information: • Information About the Applicant • Product Information • Power of attorney • Relevant certificates • Device and Site Master File • Step 4: The concerned Department will issue the Medical Import License in Form MD-15 once all the aforementioned steps have been completed and documents found satisfactory. Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  10. How we’ll help you get a CDSCO Medical Device import license? A Medical Device Import License in India under CDSCO is subject to a slew of requirements and documentation. Such requirements and documentation may be difficult to discern fully by an applicant and any mistakes in the documentation or application process could result in costly delays. As a result, it is strongly advised that you contact Regulatory Solutions India, and we will walk you through each step of the licensing process.Regulatory Solutions India, with our extensive experience in medical devices registrations, help make the process easier for our esteemed clients across the complete lifecycle starting with the application preparation and ending with the successful registration of the medical device. Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

  11. Copyright © 2023 Regulatory Solutions India All rights reserved. www.regulatory-solutions-india.com

More Related