New In-vitro Diagnostics – The lifeline of Healthcare Industry

Regulatory Body Requirement

A manufacturer or an importer who intends to conduct a Clinical Performance Evaluation of a new In-vitro diagnostic can apply through this service.

• The applicant needs to make an application to the Central Licensing Authority.
• The application can be filed in FORM MD-24 through an identified online Medical Device portal of the Ministry of Health and Family Welfare.
• The Permission to conduct a Clinical Performance Evaluation will be obtained in FORM MD-25.
• The approval is a Government process and could take approximately 1 to 2 months.

How to Apply

Any manufacturer or importer who wants to conduct a Clinical Performance Evaluation of new IVD's can apply through the following procedure:

1. The application for the Grant of Permission to conduct a Clinical Performance Evaluation of a new IVD can be made in Form MD-24.
2. The application should be addressed to the Central Licensing Authority, CDSCO.
3. The application should be submitted along with the required documents and the specified fees on the online SUGAM portal.
4. The reference regulation for this service is the Medical Device Rules, 2017.

Regulatory Body Requirement

CliniExperts can assist in obtaining a test license for manufacturing In Vitro Diagnostics (IVDs) in India. IVDs under Class A, B, C, or D can be manufactured in small quantities for various purposes such as clinical investigation, testing, evaluation, examination, demonstration or training. However, manufacturers must follow a specific set of procedures laid down by the CDSCO.

As the highest regulatory body in the country, the Central Licensing Authority maintains quality and standards for manufacturing any medical device. To manufacture a medical device, including IVDs, a manufacturer must apply to the Central Licensing Authority by submitting Form MD-12, stating the purpose for manufacturing the device. CliniExperts can guide manufacturers through this process and help obtain a test license in Form MD-13 through the online portal of the Ministry of Health and Family Welfare, which typically takes up to 30 days. Trust CliniExperts to help navigate the regulatory process and ensure compliance for manufacturing IVDs in India

How to Apply

The application is done with reference to MDR 2017. Registration on the Sugam portal is mandatory for applying for the test license

1. To apply for a test license to manufacture In Vitro Diagnostics (IVDs) in India, the manufacturer must submit an application in Form MD-12 to the Central Licensing Authority. The form should state the purpose of manufacturing the IVD, which can be for testing, evaluation, demonstration, or training.
2. Once the application is approved, the Central Licensing Authority will issue a test license in Form MD-13, which can be obtained through the online portal of the Ministry of Health and Family Welfare. The entire process of obtaining a test license can take up to 30 days.
3. It is important to note that the manufacturer must follow the procedures laid down by the CDSCO for manufacturing IVDs and maintain the quality and standards as per the regulatory requirements.

Regulatory Body Requirement

As per the provisions of Medical Device Rules, 2017, notified medical devices which need to be imported/manufactured in India, which does not have a predicate medical device, will be required to make an application using FORM MD-26. FORM MD-26 is necessary to grant permission for importing/manufacturing these medical devices. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India that grants the permission to import or manufacture new medical device in India- Form MD 26 & 27

How to Apply

1. STEP 1: Evaluation of the product, if it requires registrations as per MDR 2017
2. STEP 2: If requires registration, Evaluation of classification (Class A…….)based on the product risk category
3. STEP 3: Preparation of documents as per the MD 26 checklist
4. STEP 4: Appoint Authorized agent in case of Import of the product
5. STEP 5: Online generation of application
6. STEP 6: Before submission of application, approval/confirmation of draft application by the authorize agent/manufacturer
7. STEP 7: Follow-up with regulatory authority

Regulatory Body Requirement

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. In addition, the portal provides an interface and ease of access for applicants to track the submitted application, query responses and the ability to download permissions issued by the CDSCO.

Any applications submitted are reviewed and approved/rejected by the CDSCO. The process involves the submission of necessary documents on the online portal. After uploading the documents, applicants must submit a hard copy of the papers to the CDSCO (Medical Device Division) for further approval on the medical device portal.

How to Apply

1. Step 1: An applicant (manufacturer/importer) must have a user login id with the credential to apply on the SUGAM portal (https://cdscomdonline.gov.in/NewMedDev/Homepage).
2. Step 2: Upload all self-attested copies (documents that include the Company's name and address and issued by the Government Authority) to complete the registration.
3. Step 3: The applicant must also upload Aadhar ID Proof (Authorized person/agent), the wholesale drug license or manufacturing license, and the certificate of incorporation.
4. Step 4: The applicant must submit hard copies of all uploaded documents and the Cover letter to the CDSCO after completing online registration. After reviewing the application and all documents, the CDSCO will approve Sugam Registration.