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India is one of the developing countries emphasizing on betterment of quality of life, quality of living, and quality of infrastructure through establishment of distinct regulatory guidelines. Considering the importance of manufacturing of high quality, safety, and performance of medical devices in mind, an act, Drugs and Cosmetics Act, 1940 has been introduced.
This act is responsible for regulation of quality, performance, and safety of the medical devices (medical devices CDSCO). Moreover, to regulate the import, manufacture, clinical investigation, sale and distribution of medical devices, Medical Devices Rules, 2017 vide G.S.R. 78 (E) has been notified by the Drugs Technical Advisory Board.
Therefore, any medical device intended to be used for any medical purposes, typically used to diagnose and treat a patient to prevail over illnesses and disease, including improving the quality of life need to be certified.
As important as it is to improve the quality of life, there are certain clusters of medical devices in India, (that is Maharashtra, Gujrat, Haryana, Karnataka, Tamil Nadu, and Andhra Pradesh, Telangana) which are hub for manufacturing of medical devices. Though, considering the importance of manufacturing of medical devices, the Government of India has set a target to establish at least 25 medical device manufacturing units in each state by the year 2025.
Let’s understand the market scenario of Indian medical devices.
With the information regarding the scenario of the Indian medical industry, it can be clearly concluded that due to high dependence on import of medical devices (medical devices CDSCO), including manufacturing of medical devices in India, medical devices must be safe, tested, and certified since these are used to save lives. Thus, with the proper understanding of medical devices, let’s see which body provides medical devices approval.
CDSCO - Central Drugs Standard Control Organization is a Central Drug Authority responsible for discharging functions which are assigned to the Central Government under Central Drugs and Cosmetic Act.
Since, 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 to provide an overview of the medical devices industry covering various sub-segments: instruments and appliances, Medical Aids, diagnostic imaging, consumables and patient aids.
Medical devices under CDSCO has been classified into two categories, as discussed below -
The medical devices have been classified into distinct categories depending on risk type.
Ministry of Health and Family Welfare Notification (MOHFW) notifies of Medical Devices Rules 2017, dated on 31st January 2017, which has come into effect on 1st January 2018.
With the issuance of the notification, 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 license and approval to distinct classes of products.
Understanding distinct aspects of CDSCO registration or How do I register for CDSCO is quite complex, considering that you would have to obtain a complete knowledge in respect to classification of medical devices as per Medical Device and IVD Regulations, done by the Health Ministry of India.
That’s not all, along with the understanding of categorization of medical devices, it is also essential to demonstrate medical devices CDSCO or CDSCO approval process, including other concerned aspects.
The complexity and comprehensiveness involved in medical device registration due to lack of knowledge can impact the duration of obtaining a CDSCO certificate in a timely manner. That’s where JR Compliance comes into the picture as with the help of our CDSCO registration consultants we continue to demonstrate our ability to deliver complex solutions in respect to how I register for CDSCO.
Moreover, we are also known for our BIS certification services worldwide, providing compliance solutions to AERB approval, BEE certification, DPCC registration, EPR authorization, LMPC certification, and other compliance requirements.
Get in touch with our experts now, to meet compliance requirements for CDSCO online registration.
Class A and Class B are considered low-risk and moderate-risk devices. Low-risk devices include surgical dressing, alcohol swabs, and more. Moderate-risk devices includes Suction cup, catheters and many more.
The Drug Controller General of India (DCGI), the CDSCO (Central Drug Standards Control Organisation), Drugs & Cosmetic Acts and Rules.
The Central Drugs Standard Control Organization.
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