diagnostic-kits Regulatory Services - Registration & License

Diagnostic Kits Regulatory Services

Diagnostic Kits Regulatory Services

Diagnostic Kits play an important role in Medical science and are the base of almost every test, surgery or medical experiment. Pertaining to their importance and effectiveness in the medical field, the government of India has promulgated proper rules and guidelines for diagnostic kits in the New Medical Devices Rules, 2017, w.e.f 1st January, 2018. All the diagnostic kits whether used In-vitro or In-vivo are now regulated under the New Medical Rules 2017. Diagnostic kits either manufactured in India or imported from foreign countries require to get the license for manufacturing, sale and use in the Indian market from Licensing Authority depending upon their classification.

Following the New Medical Device Rules, 2017, all in-vitro diagnostic devices and kits have been classified into four basic categories licenses for which are allotted by respective Central and State authorities. The categorization is based upon the complexity and risk involved with using the diagnostic kit.

Diagnostic Kits Regulatory Services For Manufacturers & Importers

New In-Vitro Diagnostic Device – First time in India

Any In-Vitro Diagnostic Device which does not have a predicate or similar device in the Indian market is considered to be a New In-Vitro Diagnostic Device. Such devices need to gain approval from the Central Licensing Authority for their manufacture or Import in India.

New Diagnostic Kits License Registration & Renewal For Manufacturer and Importer

Classification of Diagnostic Kits in India

Based on New Medical Rules, the classification of the diagnostic kits takes into consideration factors like the involved risk, medical condition being diagnosed, self-testing or near patient testing. Diagnostic kits used for serious medical conditions like HIV or Cancer are classified as high-risk devices and hence placed under Class D. Other simple kits like glucose testing strips, and sphygmomanometers are placed under Class A and B.

Invitro Diagnostic Kits shall be classified in the following categories.

Risk Based Classification

Class A Low

Class B Low-Moderate

Class C Moderate-High

Class D High

The classification of the diagnostic kits takes into consideration factors like the involved risk, medical condition being diagnosed, self-testing or near patient testing. Diagnostic kits used for serious medical conditions like HIV or Cancer are classified as high-risk devices and hence placed under Class D. Other simple kits like glucose testing strips, and sphygmomanometers are placed under Class A and B.

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Overview of forms for application

CDSCO has provided various forms to be used while filing the application for permission to import or manufacture diagnostic kits. The following table contains specific form which the applicant needs to be filled.

Applicant Risk/Class Type of Licence Forms
Importer A, B, C, D Importer License Application: MD-14
Permission: MD-15
Manufacturer A, B Manufacturing License Application: MD-3
Permission: MD-5
Loan License Application: MD-4
Permission: MD-6
C, D Manufacturing License Application: MD-7
Permission: MD-9
Loan License Application: MD-8
Permission: MD-10
Importer A, B, C, D Clinical Performance Evaluation Application: MD-24
Permission: MD-25
Manufacturer A, B, C, D Clinical Performance Evaluation Application: MD-24
Permission: MD-25
Importer (New In-Vitro Device) A, B, C, D Import License Application: MD-28
Permission: MD- 29
Manufacturer (New In-Vitro Device) A, B, C, D Manufacturing License Application: MD-28
Permission: MD- 29

For Importers

India has developed at a staggering rate as an economy. Hence the demand for medical care equipment has skyrocketed in the recent years. The new medical rules have classified all the existing diagnostic kits, including those which were earlier not classified. Filing an application for obtaining an import license is a simple single step process now. The process has been simplified to expedite the process and ensure proper availability of diagnostic kits in the country. The New Medical Device Rules allow multiple importers of a single diagnostic kit which was forbidden earlier. Although, each importer has to file a separate application for each diagnostic kit being imported.

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Import License Process

Classification of Medical Device
Classification
of Medical Devices

Authorized Agent / Registration Holder Support
Authorized Agent /
Registration Holder
Support

Application Filing
Aplication Filing
(Form MD- 14)

Import License
Import Licence
(Form MD- 15)

Authorized Agent / Registration Holder

All the applications for import of diagnostic kits will be filed by Authorized agent only. Foreign manufacturer cannot file an application directly to CDSCO. Authorized agent means a person including any firm or organization who has been appointed by an overseas manufacturer through a power of attorney to undertake import of diagnostic kits in India.

We at CliniExperts hold a valid Wholesale License (Form 20B and 21B) enabling us to act as Authorized agent for our clients which helps reduce the time of foreign manufacturer to set up their office in India and expedite the launching of the product.

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Permission for Import License (Form MD-14, Form MD-15)

An application for issue of an Import License (Form MD- 15) shall be made to the central licensing authority in Form MD- 14. The authorized agent in India having a valid whole sale license for sale or distribution can apply for the Import License in MD-14 on behalf of the manufacturer. Our technical team at CliniExperts help our clients to obtain Import License.
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Permission for Test License to Import In-Vitro Diagnostic Kit (Form MD-16, Form MD-17)

Any diagnostic kit can be imported in small quantities for the purpose of clinical investigations or test or evaluation or demonstration or training.

Importer who desires to import diagnostic kit, shall apply for an import license for test, evaluation or demonstration or training to the Central Licensing Authority in Form MD-16. Permission to import will be granted in MD- 17.

CDSCO has specified few diagnostic kits whose Performance Evaluation from NIB, Noida is mandatory prior to grant of license. For NIB testing, test license is required to be obtained. CliniExperts helps the client to obtain a Test License for testing and analysis of samples at NIB, Noida.

We at CliniExperts possess knowledge of the laws and regulations relating to the development, testing, approval and manufacture of kits.

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For Manufacturer

New Medical Device Rules, 2017 have defined distinct provisions to obtain permission for manufacturing of diagnostic kits in India. Different diagnostic kits have been classified under different categories based upon their use, complexity and the risk involved. Applications for Class A and Class B diagnostic kits are reviewed and granted permission by the State Licensing Authorities. Whereas applications for Class C and Class D medical devices are reviewed and granted license by the Central Licensing Authority. This difference is obviously due to the depth and scale of review involved for different classes of diagnostic kits. CDSCO has also defined different fees for different classes of diagnostic kits.

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Manufacturing License for Invitro Diagnostic Kits from SLA/CLAA

Permission to Manufacture or Permission for loan license to manufacture Class A & B Diagnostic Kits in India from State FDA (Form MD-5 and Form MD-6)

Any company planning to manufacture Class A and B diagnostic devices must obtain a permission to manufacture from the State FDA. Since Class A and B devices as classified as low to moderate risk, and the application review process for them is quite simple and less stringent. Any manufacturer who needs a loan to manufacture diagnostic kits must first obtain a loan license from the State Licensing Authority to apply for a loan. Cliniexperts will help you in filing a manufacturing and/or loan license for Class A and B diagnostic kits
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Permission to Manufacture or Permission for loan license to manufacture Class C & D Diagnostic Kits in India from CDSCO (Form MD-9, Form MD-10)

Class C and D diagnostic kits have a fair amount of risk involved with them, thus their license application and approval process is quite stringent. The permission to manufacture these devices is thus filed and obtained from the Central Licensing Authority using form MD-9. A manufacturer trying to procure a loan for manufacturing these diagnostic kits must obtain a license to apply for the loan.

Cliniexperts has helped a lot of clients file and obtain manufacturing and loan license for Class C and D medical devices. Our fantastic team of experts and regular follow-ups helps in expediting the process and improving the chances of approval.
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Permission for test license to manufacture Diagnostic Kits  (Form MD-12, Form MD-13)

Diagnostic kits can be manufactured in small quantities for the purpose of test, clinical investigation, demonstration or training. A test license to manufacture such diagnostic kits has to be obtained from the Central Licensing Authority. The test license can be filed for any class of medical devices. The application is filed using form MD-12 and the permission is granted in Form MD-13. Cliniexperts helps you in filing the application accurately to improve your chances of approval. Our team of experts ensures that the application process is hassle free and quick.
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New In-Vitro Diagnostic
First Time in India

New In- Vitro Diagnostic Device are the devices that has not been approved for manufacturing or importing by Central Licensing authority

A New In-Vitro diagnostic kit is one whose similar or predicate device is not available in India. Such diagnostic kits need to undergo clinical investigations to prove their safety and effectiveness. This Clinical Performance Evaluation is conducted on specimens collected on voluntary human participants. Once the clinical performance evaluation has been completed a report describing the results of the investigation is generate. An application for the import or manufacture new In-Vitro Device is filed at the Central Licensing Authority, along with this performance evaluation report. After proper evaluation of the report’s findings, a permission is granted by the CLA to import or manufacture the diagnostic kit in India.

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Permission to conduct Clinical Performance Evaluation for New In-Vitro Diagnostic (Form MD-25)

Any new in-vitro diagnostic kit has to undergo a clinical performance evaluation. The application to obtain permission for this evaluation for any class of medical device has to be filed at the Central Licensing Authority using Form MD-25. Preparing and filing the application in the right format is mandatory to ensure positive chances of approval. Cliniexperts has precisely trained staff to help you prepare the application and attach finding of the Clinical Performance Report in the proper format. Our skilled team and resources ensure that your application gets approved as soon as possible.
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Permission to import/manufacture New In-Vitro Diagnostic which does not have a predicate kit (Form MD-29)

Once Clinical Performance Evaluation is done, the applicant needs to submit application for import/manufacture New In-Vitro Diagnostic. The application consists of data generated by the client.

Our team focuses on quality attributes as well the scientific rationale of the New device application.
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