In-Vitro Diagnostic 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.
Classification of Diagnostic Kits in India
Based on New Medical Rules, the classification of the in-vitro diagnostic kits takes into consideration factors like the involved risk, medical condition being diagnosed, self-testing or near patient testing. IVD kits are 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.
In-vitro 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.
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 License
Forms
Importer
A, B, C, D
Type of 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-14 Permission: MD-15
----
----
Type of License
Application: MD-8 Permission: MD-10
Importer
A, B, C, D
Clinical Performance Evaluation
Application: MD-14 Permission: MD-15
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.
Import License Process
Classification of Medical Devices
Authorized Agent / Registration Holder Support
Application Filing
(Form MD- 14)
Import Licence
(Form MD- 15)
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.
Manufacturing License for Invitro Diagnostic Kits from SLA/CLAA
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.
Related Services
Import License For In-Vitro Diagnostic Kits in India – Form MD14 & MD15
The license to import in-vitro diagnostic kits (IVD) is regulated in India under two regulatory provisions – Drugs & Cosmetics Act 1940 and Drug & Cosmetics Rule 1945. Import license for in-vitro diagnostic is received in “Form MD 15” as per Medical Device Rules 2017.
Importer | Regulatory Body: CDSCO
Authorized Agent Support In-Vitro Diagnostic Kits
In India, the manufacturing, import, sale and distribution of medical devices are regulated under the Drugs and Cosmetics Act and Rules by The Central Drugs Standard Control Organization (CDSCO).
Importer | Regulatory Body: CDSCO
Clarification Letter / No Objection Certificate for In-Vitro Diagnostic Kit
The Central Drugs Standard Control Organisation (CDSCO) is the Indian regulatory body that governs the safety, efficacy, and performance of medical devices. The CDSCO also provides clarity to importers and manufacturers regarding the regulatory status of the product.
custon-fontImporter | Regulatory Body: CDSCO
Test License to Import In-vitro Diagnostics in India
The regulatory body of India has laid down provisions for non-notified medical devices. The products already under the notified category of the medical device are excluded from this category.
Importer | Regulatory Body: CDSCO
IN-VITRO DIAGNOSTIC KITS LABEL COMPLIANCE
The registration process for medical devices is primarily done on the SUGAM portal, a website where the applicants apply for approval of licenses, FSC and Registration numbers.
Importer | Regulatory Body: CDSCO
Permission For Test License To Manufacture In-Vitro Diagnostic Kits (IVD) – (Form MD 12, MD 13)
A medical device under Class A, B, C, or D can be manufactured in small quantities for various purposes; for instance, a medical device can be used for clinical investigation, testing, evaluation, examination, and demonstration or training.
custon-fontImporter | Regulatory Body: CDSCO
Permission to Manufacture Class C & D In- Vitro Diagnostics in India
For manufacturing an in-vitro diagnostic medical device (IVD) of Class C & D, a Manufacture license must be taken before starting the manufacturing process. Any manufacturer who intends to produce a device at a site where the same device is being produced by another manufacturer must get a Manufacture license.
Importer | Regulatory Body: CDSCO
Post Approval Changes For In-Vitro Diagnostic Kits
The license to import in-vitro diagnostic kits (IVD) is regulated in India under two regulatory provisions – Drugs & Cosmetics Act 1940 and Drug & Cosmetics Rule 1945. Import license for in-vitro diagnostic is received in “Form MD 15” as per Medical Device Rules 2017.
Importer | Regulatory Body: CDSCO
Permission for Loan License to Manufacture Class A & B In- Vitro Diagnostics in India
The license to import in-vitro diagnostic kits (IVD) is regulated in India under two regulatory provisions – Drugs & Cosmetics Act 1940 and Drug & Cosmetics Rule 1945. Import license for in-vitro diagnostic is received in “Form MD 15” as per Medical Device Rules 2017.
custon-fontImporter | Regulatory Body: CDSCO
Free Sale Certificate For IVD
A free sale certificate, also known as a “Certificate for Export” is a document issued by the national regulatory authority. The Central Drugs Standards Control Organization (CDSCO) streamlines the application process for free sale certificate for notified In-vitro diagnostic kits in India.
Importer | Regulatory Body: CDSCO
Assistance in ISO 13485 Certification in India in India
The purpose of this service is to assist in ISO 13485 certification process. ISO 13485 Certificate is an important Certification required by the manufacturers, designers, suppliers, distributors, and service providers of all medical devices including in vitro devices (IVDs).
Importer | Regulatory Body: CDSCO
Permission to Manufacture Class A & B In Vitro Diagnostics in India
The purpose of this service is to obtain license to manufacture Class A and B IVD’s in India. The State Licensing Authorit is the regulatory body associated with this service. It grants the license to manufacture IVDs for sale or distribution in FORM MD-5 as per Medical Device Rule 2017.
custon-fontImporter | Regulatory Body: CDSCO
Permission for Loan License to Manufacture Class C & D In- Vitro Diagnostics in India
A Loan manufacturing license in FORM MD-10 is needed by any manufacturer, as per provisions of the Medical Device Rules, 2017 for manufacturing the IVD’s of Class C & Class D (Notified) in India.
Importer | Regulatory Body: CDSCO
Registration For Non-Notified In Vitro Diagnostic in India
All non-notified In-vitro Diagnostic (IVDs) medical devices, excluding those already under the notified category of the medical device need registration with the CDSCO.
Importer | Regulatory Body: CDSCO
Test License to Import In-vitro Diagnostics in India in India – MD 16 & MD 17
The Central Drugs Standard Control Organization (CDSCO) has issued a notice stating that a small number of medical devices might be imported into India. The devices belonging to Class A, Class B, Class C, or Class D may be imported in small quantities to India based on Test License in Form MD-17.
custon-fontImporter | Regulatory Body: CDSCO
Insight
India Champions e-Governance for Pharma Industry
National e-Governance plan (NeGP), launched in 2006 as initiative that Government of India has implemented to make all government services accessible online.
Drug | DCGI | Ethics | Committee | DGFT | ICMR | NeGP | MoHFW | MoCI | CDSCO | India | India Regulatory Services
Insight
Sugam Portal – CDSCO Sugam Registration for Online Application
Indian Government has chosen to join the foray and ride the digital wave through SUGAM, launched on 14 November, 2015
Drug | DCGI | India | India Regulatory Services
Insight
New Regulations for Medical Devices Industry by CDSCO
Nowadays, therapeutic treatment based on medical devices is providing technologically advanced solutions for the management, diagnosis, treatment,mitigation or prevention of several diseases. Thus, the demand continues to grow in
Insight
New Regulations for Medical Devices Industry by CDSCO
Nowadays, therapeutic treatment based on medical devices is providing technologically advanced solutions for the management, diagnosis, treatment,mitigation or prevention of several diseases. Thus, the demand continues to grow in
Insight
New Regulations for Medical Devices Industry by CDSCO
Nowadays, therapeutic treatment based on medical devices is providing technologically advanced solutions for the management, diagnosis, treatment,mitigation or prevention of several diseases. Thus, the demand continues to grow in