How to Get Medical Devices Approval | CDSCO Certificate
India is one of the developing countries emphasizing on the betterment of the quality of life, quality of living, and quality of infrastructure through emphasizing on the establishment of distinct regulatory guidelines. Considering the importance of manufacturing high-quality, safe, and ideal performance of medical devices in mind, an act, Drugs, and Cosmetics Act, of 1940 has been introduced.
This act is responsible for the regulation of quality, performance, and safety of 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, which are typically used to diagnose and treat a patient to prevail over illnesses and disease, including improving the quality of life required to obtain an MDR CDSCO certificate.
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. 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.
Indian Medical Device Market Scenario
- The Indian medical device sector’s estimated growth in 2021 was USD 10 billion.
- India is dependent on the import of medical devices by 70% to 80%, while India had exported USD 2.1 billion in 2019, and its CARG is expected to rise by 29.7% to reach USD 10 billion in 2025.
- The major countries with whom India is engaged in importing medical devices are the US, China, Brazil, and others.
With the information regarding the scenario of the Indian medical industry, it can be clearly concluded that due to the high dependence on the 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 device 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 that 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, India 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.
Classification of Medical Devices
The medical devices have been classified into distinct categories depending on the risk type.
|Class||Risk category||Examples of medical devices|
|A||Low||Surgical dressings, Syringes, etc|
|B||Low moderate||Surgical gloves, pregnancy Kits, etc|
|C||Moderate high||Lung Ventilators, Anesthesia, etc|
|D||High||Heart & Lung Bypass Unit, Pacemakers, Implants, etc|
To certify or approve any of the product categories as Category C and D, to be imported, manufactured, or distributed in India, Central Drug Government will be directly involved, considering the usage of these devices involves high risk.
JR Compliance - India’s leading compliance service provider is equipped with CDSCO registration consultants and resources to provide you complete assistance in completing the medical device certification duly and aptly.
Be it guiding our clients throughout the CDSCO registration process (How do I register for CDSCO), and no one can be as reliable and credible in duly completing CDSCO online registration as JR Compliance since, we possess the expertise, knowledge, and experience of 9+ years providing compliance services to globally recognized brands such Softbank, Samsung, Toray, Sennheiser, and more.
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 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 licenses and approval to distinct classes of products.
Central Licensing Authority (CLA) - CLA is entrusted to provide licenses 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.
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.
How to Obtain A Manufacturing License for Class A & Class B Medical Devices | How Do I Register For CDSCO?
- Respective 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 the 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 the case of Class B devices, an inspection will be conducted by Notified body within 90 days of submission of the application.
- The audit report will be submitted to SLA and a grant of the license will be provided after scrutinization of the reports.
The process to Obtain a 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.
How Will We Make CDSCO Registration Seamless?
- 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 whether 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 with respect to medical devices CDSCO registration (How do I register for CDSCO).
Understanding distinct aspects of CDSCO registration or How do I register for CDSCO is quite complex, considering that you would have to obtain complete knowledge with respect to the 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 a 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 with respect to how I register for CDSCO.
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