MDR CDSCO - A Certificate For Medical Devices

JR Compliance guarantee to provide you 100% assistance in MDR CDSCO registration by maintaing the transparency. Also, we are action-oriented, thus, we will invest our sustain efforts in completing the medical devices CDSCO process immediately. 

To know more about how to get an MDR license, contact us immeditely.

Why Medical Devices Need CDSCO Certificate?

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.

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Indian Medical Device Market Scenario


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.

Which Body Provides Medical Devices Registration | Medical Devices CDSCO

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.

Classification of Medical Devices

Distinct Bodies Involved in CDSCO Online Registration

What Are the Notified Bodies For Medical Devices in India?

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. 

State Licensing Authority (SLA)

SLA has been entrusted with the responsibility of providing manufacturing, loan, and wholesale license to medical devices under Class A and Class B. SLA also assigns a notified body to validate the Quality Management System (QSM) requirements and technical review of medical devices under Class A and Class B manufacturers.

Central Licensing Authority (CLA)

CLA is entrusted to provide license to all the imported medical devices in India, including providing manufacturing, loan, and wholesale license to medical devices under Class C and Class D. Moreover, CLA might provide services of a notified body to inspect the manufacturing site/ location and technical review of medical devices under Class C and Class D.

How to Obtain A Manufacturing License for Class A & Class B Medical Devices | How Do I Register For CDSCO

MD - 3 forms will be duly submitted through the online Sugam portal of the Ministry of Health.

Required documents will be attached.

Declaration for compliance with Quality Management System will be aptly submitted

Document scrutinization will be done by the State Licensing Authority (SLA).

In case of Class A devices, if applications ensure compliance with requirements, the Notified body will conduct an audit within 120 days from the Grant of License.

In case of Class B devices, an inspection will be conducted by Notified body within 90 days of submission of application.

Audit report will be submitted to SLA and grant of license will be provided after scrutinization of the reports.

Process to Obtain Manufacturing License for Non-notified Medical Devices | CDSCO Certificate For Non-notified Medical Devices

Registration will be duly done through the official website.

Required documents such as ID proof, undertaking, corporate address details, etc will be attached.

Validation of registration will be done through OTP submission.

After completion of self-verification, login credentials will be used to log in.

Our Role in MDR CDSCO

Our cdsco registration consultants will educate you concerning every aspect of the IMDR CDSCO registration (How do I register for CDSCO).

We will check under which Class your products fall, including whether a product complies with the CDSCO standards or not, then, after mutual understanding, the project will move forward.

Obtaining a CDSCO certificate/ CDSCO online registration is no easy task, however, there is no better place to obtain it than JR Compliance because we will analyze the product requirements to give clear guidelines.

Our CDSCO registration consultants are equipped with the necessary resources to conduct a virtual pre-audit to confirm that your manufacturing unit is complying with CDSCO requirements (medical devices approval) or not.

Our CDSCO consultants will coordinate with the concerned authorities for regular follow-ups.

You can expect reliable and punctual service delivery as our cdsco registration consultants will also visit the CDSCO office on your behalf if required to complete CDSCO online registration on time.

Our IMDR CDSCO consultants will invest their sustained efforts to meet the startled queries or demands of concerned authorities.

In case of any concern regarding CDSCO license/ cdsco online registration, we assure to provide the finest solution in respect to medical devices CDSCO registration (How do I register for CDSCO).

Conclusion

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.


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