CDSCO Medical Device Registration for IVD Lab Kit
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CDSCO Medical Device Registration for IVD Lab Kits
The CDSCO, which functions under the aegis of the Directorate General of Health Services, GoI is the National Regulatory Authority of India, regulating the safety, quality, and efficacy of drugs, medical devices, and cosmetics available in the country. The role of CDSCO is of critical importance in the regulation of healthcare products prior to entering the market.
In recent years, the scope of medical device regulations has grown significantly, including diagnostic products like IVD Lab Kits. Businesses that are involved in manufacturing, importing, and distributing medical devices need to register themselves under CDSCO to ensure that the medical devices meet the set standards.
The process of dealing with regulatory approvals for medical devices involves technical documentation, regulatory knowledge, and proper filing of applications. With more than a decade of experience in managing regulatory registrations and compliance services, Professional Utilities help businesses in dealing with the CDSCO registration process in a smooth manner.
Procedure For CDSCO Medical Device Registration for IVD Lab Kits
Structured regulatory procedure from portal registration to license issuance are as follows:
- Step 1: Register on the SUGAM Portal : – Applicants must first visit the official CDSCO website and register on the SUGAM portal, which serves as the online platform for submitting regulatory applications.
- Step 2: Complete Applicant Information : – After registration, the applicant must fill in the Applicant Registration Form, providing the required personal and organizational details.
- Step 3: Upload Required Documentation : – All necessary documents must be submitted through the portal so that CDSCO officials can begin the verification process.
- Step 4: Verify Email Confirmation : – A confirmation link is sent to the registered email address. Clicking this link activates the applicant’s account on the SUGAM portal.
- Step 5: Authority Review and Evaluation : – Once the application is submitted, the concerned CDSCO officials review the documents and assess the regulatory compliance of the product.
- Step 6: Grant of Registration License : – If the documentation and regulatory requirements are satisfied, CDSCO grants the license allowing the manufacture, import, or distribution of the IVD lab kits.
Documents Required for CDSCO Registration of IVD Lab Kits
The following documents are generally required for obtaining CDSCO medical device registration for IVD lab kits:
- Power of Attorney
- Details according to Annexure B (HIV, HBV, HCV, and Blood Grouping Sara)
- TR6 Challan
- Wholesale Drug License
- ISO Certificate-13485
- CE Design Certificate
- Complete Quality Assurance Certificate
- Declaration of Company
- Plant Master File
- Device Master File
- FSC (Free Sale Certificate)
- PMS Report (Post-Market Surveillance Report)
- Performance Evaluation Report of Products
- Original labels and pack sizes
CDSCO Registration Fees for IVD Lab Kits
The total fee for CDSCO registration for IVD Lab Kits with Professional Utilities is INR 1,02,999 /- only, including the government fees.
Understanding IVD Lab Kits as Regulated Diagnostic Devices
In-Vitro Diagnostic (IVD) devices are medical test tools that help analyze samples collected from the human body, such as blood, tissue, or swabs, to diagnose diseases, infections, and other health conditions. IVD test tools play a vital role in various medical labs, hospitals, and healthcare centers to enable healthcare experts to diagnose various medical conditions effectively and efficiently.
Manufacturing, importing and selling of IVD Lab Kits are labeled as Drugs in India. CDSCO Registration for IVD Lab Kits is a process of obtaining a manufacturing license for IVD Medical Devices by the manufactures to perform certain activities as Manufacture, Import, Clinical Performance, Sale and Distribution of IVD Medical Devices or Lab Kits in India.
IVD Medical Devices shall be classified into different classes based on their risk levels as:-
- Class A - Low Risk
- Class B - Moderate Low Risk
- Class C - Moderate High Risk
- Class D - High Risk
Importance of CDSCO medical device registration for IVD Lab Kits
Medical Device Registration for IVD Lab Kits carries a significant importance which are as follows:
- Regulatory Compliance: CDSCO Registration provides Regulatory Compliance, referring to a procedure of following relevant laws and regulations. CDSCO's objective is to safeguard the public health.
- Safety & Quality of Products: CDSCO registration ensures that Medical Devices don't include any harmful preparations and are suitable for all, assuring that the products are safe to be consumed by the masses.
- Unlock Market Access: CDSCO Registration is required before dealing with Drugs and Medical Devices. It makes sure that they are free of heavy metals and other toxins for being safe to be consumed by the masses. It provides new opportunities in the Market.
Start Your CDSCO Registration for IVD Lab Kits with Expert Guidance
CDSCO aims to strengthen its transparency and accountability in the regulations of medical devices and diagnostic kits across the nation. It has now become a mandatory requirement for businesses operating in the healthcare and diagnostics industry to secure the appropriate manufacturing and/or import license for IVD Lab Kits license, X-ray machine license, ultrasound machine license, CT scan machine license, MRI machine license, and other diagnostic and radiology equipment licenses.
With more than a decade of experience in regulatory consulting and licensing support services, Professional Utilities provide trusted and reliable assistance for CDSCO medical device registration. Our team of experts assist businesses prepare the necessary documentation and applications, and work with the relevant authorities to ensure a smooth process.
FAQ’s On CDSCO Certificate for IVD Lab Kit
What are IVDs?
IVDs are In Vitro Diagnostics Medical Devices that are used to test human samples.
Why is CDSCO certification required for BP monitors?
CDSCO certification for BP monitors is mandatory to ensure accurate blood pressure measurement, patient safety, and compliance with Indian medical device quality and performance standards.
Do IVD lab kits require separate CDSCO registration from other
medical devices?
Yes, IVD lab kits are classified under specific regulatory categories and require their own CDSCO registration. For other devices like digital thermometers, you can refer to the CDSCO Medical Device Registration for Digital Thermometer for separate compliance requirements.
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