Significance of In-Vitro Diagnostics in Healthcare
In modern healthcare, In-vitro diagnostics (IVD) has revolutionized the way we diagnose, monitor, and treat diseases. It is not a big surprise if you don’t have enough information about vitro diagnostics. As per WHO, “In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections.” In vitro simply means ‘in glass’, meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.”
Keeping the importance and effectiveness of IVD in mind, the Indian government under Central Drugs Standard Control Organization (CDSCO) has formulated Medical Device Rules 2017 for regulations for in-vitro diagnostics medical devices to be manufactured and imported. Under the Medical Devices Rules 2017, one can import, manufacture, sell, and distribute In Vitro Diagnostics Medical Devices in India.
Proper knowledge of Medical Device Rules 2017 will help to obtain licenses for In-vitro diagnostics devices. Being a top IVD medical device regulatory service provider, our team assist more than 100 clients to successfully enter the Indian Market by completing all legal processes. We offer regulatory consultation services that combine precision, reliability, and efficiency.
Diagnostic tests act as a fire defense against the spread of many diseases. The significance of In-vitro diagnostic kits cannot be overlooked when it comes to upgrading the point-of-care testing and making informed decisions. With us, you can take the advantage of IVD regulatory consulting and process your application accordingly.
Dynamics of In-Vitro Diagnostic Medical Devices
The in-vitro diagnostics market is growing at a CAGR of 3.3% from 2022 to 2027 and is poised to reach $138.4 billion by 2027.
Recently, the Production Linked Incentive Scheme (PLI 2.0) has been launched by the Indian government to enhance the potential of the IVD sector.
In India, IVD products are registered according to the provisions of Medical Device Rules 2017 and categorized according to risk factors.
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IVD (In-Vitro Diagnostic Medical Devices) Classification
In the realm of healthcare, In-vitro diagnostic medical devices upgrade the quality of diagnosis for priority diseases. In India, the Central Drugs Standard Control Organization (CDSCO) manages IVD medical devices or In-Vitro Diagnostic Import License under the provisions of the Medical Devices Rules, 2017.
As per the medical device rules, IVDs are classified into four categories based on risk, medical condition, near-patient testing, or self-testing. While sharing IVD regulatory consulting, we make sure to offer complete assistance to our clients to let them understand the process and their licenses accordingly.
Risk Based IVDs Classification:
Class A (Low Risk)
Class B (Low-to-Moderate Risk)
Class C (Moderate-to-High Risk)
Class D (High Risk)
The import, manufacturing, sale, and distribution of IVD medical devices are regulated as Drugs under sub-clause (i) of clause (b) of section 3 and sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetic Act and Rules.
Our team handles the process and knows when to approach the Central Licensing Authority (CLA) or the State Licensing Authority (SLA) to resolve the in-vitro medical devices related matters.
Under the Drugs & Cosmetics Act 1940, In-vitro diagnostic kits/reagents are notified for HIV, HBV, HCV, and blood grouping sera and regulated under the provisions of the Medical Devices Rules, 2017.
Import License For IVD
To make a strong move in vitro diagnostic medical devices to embark on your journey in the vibrant healthcare landscape in India, you must know the market dynamics. We are here to help you out and offer unbreakable support to get your Import License for IVD smoothly.
The process of getting an In-Vitro Diagnostic Device Import License unfolds the predominance of four steps: classification of IVDs, connection with authorized agents, application filing (Form MD-14), and import license (Form MD-15)
Support from Registration Holder/Authorized Agent
In order to proceed with the process of import license for in-vitro medical devices, you need to file for import registration under Indian laws. According to the Indian government, foreign manufacturers are not allowed to apply directly to CDSCO. They need to connect with an Authorized agent to submit their application.
Holding a valid License (Form 20B & 21B or Form MD-42), we offer top-notch in-vitro diagnostic devices regulatory services and convert an application to approval. With us, you can reduce the time and stress of getting an import license.
Import License: Form MD-14 & Form MD-15
Under the provisions of the Medical Device Rules 2017, one needs to fill out the Form MD-14 to the central licensing authority to get an IVD import license and receive the approval in the Form MD-15.
An authorized agent in India with a valid wholesale license for sale or distribution can apply for the license on behalf of the manufacturer. At Dueran Consultant, our team works dedicatedly to address the issues of our clients and satisfy them with our endeavors and knowledge.
Test License to Import Diagnostic Kit: Form MD-16 & Form MD-17
A diagnostic kit is imported to perform clinical investigations, tests or evaluations or Demonstration or training. If you need to apply for a Test license, then you must submit the application to the Central Licensing Authority in Form MD-16. Your import license for Test will be ed in Form MD-17.
While applying for an import license, CDSCO asks manufacturers to submit performance evaluations report from NIB (National Institute of Biological) in cases of a few diagnostic kits. As an experienced regulatory service provider, we help you to obtain a test license by completing all formalities correctly.
Manufacturing License for IVD Form MD-3, Form MD-5, Form MD-7 & Form MD-9
The Medical Device Rule 2017 shares the complete information related to ing the license for manufacturing, sale, and distribution of diagnostic kits. Depending on the classification, you must connect with the responsible authority to obtain your manufacturing license.
For a of license to manufacture for sale Class C or Class D in-vitro diagnostic medical devices, you need to fill the Form MD-7 & approval is ed by Authority in Form MD-9; and for Class A or Class B in-vitro diagnostic medical devices, you require application in Form MD-3 & approval is obtained in Form MD-5.
The Central Licensing Authority (CLA) manages the manufacture of Class C and Class D IVDs whereas the State Licensing Authority (SLA) is responsible for enforcement in matters related to manufacture for sale or distribution of Class A or Class B IVDs. Backed with experienced professionals, we approach the right authority to the manufacturing license for our clients.
Loan License to Manufacture for Sale or Distribution: Form MD-4, Form MD-6, Form MD-8 & Form MD-10
CDSCO defined everything in a proper format so that any applicant can apply for a loan license. For a of loan license to manufacture for sale Class C or Class D in-vitro diagnostic medical devices, you need to fill the Form MD-8 & approval is ed by Authority in Form MD-10;
Application for Class C & Class D In-Vitro Diagnostics kits demands requisite documents and fees to be submitted to the Central Licensing Authority (CLA). Lack of knowledge will not help to proceed with the application; So, allow us to assist you in the process of getting a manufacturing license.
The State Licensing Authority handles the formalities for manufacturing Class A and B diagnostics kits in India. The process is quite simple as Class A and B in-vitro medical devices come under low to moderate risk.
To obtain a Loan license for the intended In-vitro diagnostic kits and reagents in Class A & B, filed in Form MD-4 is needed and approval is ed in Form MD-6.
Test License to Manufacture IVDs For Test, Evaluation, Clinical Investigations: Form MD-12 & Form MD-13
Application to conduct Clinical Performance Evaluation (Form MD-24 and approval in Form MD-25)
When manufacturers and importers need to conduct a clinical performance evaluation of new in- vitro diagnostic Medical devices, they have to obtain permission from Central Licensing Authority. It can be done by submitting an online application in Form MD-24. Complete the form with the correct details or you can ask our experts for further information to submit your application without any hurdle.
Permission to manufacture/ Import New In-Vitro Diagnostic Medical Device:
(Form MD-28 and approval in Form MD-29)
Are you looking for getting a Manufacture/ import license for a new In- Vitro Diagnostic medical device? Then, you need to connect with our experienced professionals and gain knowledge of Form MD-28 and Form MD-29. Through Form MD-28, you can apply for approval of new In- Vitro Diagnostic Medical Devices and seek permission to import or manufacture the same through Form MD-29.
Other Certificates
Free Sale Certificate
Are you willing to export In- Vitro Diagnostic medical devices from India? We are here to help you to get a Free Sale Certificate from the Licensing Authority. Our experts streamline the application process for getting the certificate on time.
Market Standing Certificate
Marketing Standing Certificate is essential certificate for companies participating in various tenders in India. If it gets complicated for you to get the Market Standing Certificate, you can connect with us and seek our professional guidance to understand the process completely.
Non-Conviction Certificate
With more than a decade of experience, we provide the required assistance to our clients to obtain Non-conviction certificate of In Vitro Diagnostic Medical Devices. We make your application submission to CDSCO successful.
Neutral Code Certificate
If Foreign Buyers are not interested to reflect the name and address of manufacturing company on product labels, you can seek a Special code certificate or Neutral code certificate. Submit your application to CDSCO and get permission for export of In Vitro Diagnostic Medical Devices.
Miscellaneous Services
Any Post Approval Changes, Shelf Life Extension of In Vitro Diagnostic Medical Devices, and or any other services related to In Vitro Diagnostic Medical Devices approval from CDSCO.
