CDSCO Registration | MDR CDSCO Registration | Medical Devices Approval | MDR License

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👉🏽 CDSCO Registration | MDR CDSCO Registration | Medical Devices Approval | MDR License
▶ In this video, our veteran Project Manager will apprise you with the information related to medical device registration, including product classification and how to complete the MDR CDSCO registration process.
▶ India is the major importer of medical devices, if compared to other countries, offers a steady market opportunity for global Medical Device (MD) manufacturers. Considering the product quality assurance of medical devices for substantial growth of the Indian medical device industry is expected to operate in accordance with upcoming regulatory guidelines, that is IMDR 2017 issued by CDSCO.
▶ This step has been taken to establish the importance of medical devices in the healthcare industry, including providing an overview of the medical devices industry covering various sub-segments: instruments and appliances, Medical Aids, diagnostic imaging, consumables, and patient aids.
▶ With an understanding of what is IMDR 2017, let’s have a look at product classification.
The medical devices have been classified into distinct categories depending on risk type, Class A and B including products with low and low moderate risk, respectively. Conversely, classes C and D include moderate-high and high-risk products, respectively.
▶ Since the product category under MDR CDSCO is clear, let’s have a look at notified bodies in medical devices. Here, the Ministry of Health and Family Welfare Notification (MOHFW) notifies of Medical Devices Rules 2017, dated 31st January 2017, which has come into effect on 1st January 2018.
▶ With the issuance of the notification, the Central Licensing Authority (CLA) and State Licensing Authority (SLA) have been entrusted with the responsibility to provide licenses to manufacturers, importers, and distributors of medical devices.
▶ Moreover, it is to be noted that both the mentioned authorities, Central Licensing Authority (CLA) and State Licensing Authority (SLA) are responsible for providing licenses and approval to distinct classes of products.
▶ With that, finally, move on to how to obtain an MDR CDSCO license,
▶ The first relevant form will be submitted through the online Sugam portal of the Ministry of Health.
▶ Required documents will be attached.
▶ Declaration for compliance with QMS will be aptly submitted.
▶ Document scrutinization will be done by the SLA and CLA.
▶ In the case of Class B devices, an inspection will be conducted by Notified body within 90 days of submission of the application.
▶ An audit report will be submitted to SLA/ CLA and a grant of the license will be provided after scrutinization of the reports.
▶ In the case of products under Class C and D, inspection will be conducted by competent officials.
▶ Here is all you need to know about MDR CDSCO, however, in case of more information, get in touch with us right away.
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