When you have to import any of the IVD devices in India then you must apply import License for InVitro Diagnostics Medical Devices. The IVD medical devices required compliance in India as per the Medical Device Rules 2017, under the Drugs and Cosmetics Act, 1940. The license approval is regulated by the Central Drugs Standard Control Organization (CDSCO).
To obtain the license you have to go with the mentioned steps in this content or you can simply connect with the expert team of medical device regulatory in India ELT Corporate to make it easy and quick.
An Overview of Apply for an InVitro Diagnostic Import License
An IVD device is a medical product used to collect biological samples such as blood, urine, or tissues outside the human body for medical diagnosis, disease detection, or monitoring health conditions. Import of InVitro Diagnostic is governed by New Medical Device Rules, 2017, in India. CDSCO (Central Drugs Standard Control Organization) has an online platform of SUGAM portal for issuing permits and submitting applications to Import InVitro Diagnostic falling by any Category A, B, C, or D respective online form is required to submit on SUGAM is a central Licensing Authority for such products.
Procedure To Apply Import License For InVitro Diagnostics
The Procedure to apply for an InVitro Diagnostic import license is follows:
Initially, an evaluation of the product is to be done to ascertain whether it meets the basic norms needed to file an application for an import license as per the Medical Rule of 2017. The competent authority should do the evaluation process.
For the registration according to the Medical Device Rule, 2017, classification of the In Vitro Diagnostic Medical Device is done based on the Product Risk category.
Documents required according to the New Medical Device Rule 2017 should be kept ready and should also be duly signed by the signatory authority.
An agent who has a license to manufacture a Medical Device and In Vitro Devices for sale and distribution is to be appointed via Power of Attorney by an Overseas Manufacturer.
An application form is generated online. With all its attachments the form should be duly filled.
An authorized agent is to be approved to submit the draft application form.
Follow-up with the Regulatory Authority and query management can be done in case of any doubt.
If all needed norms and guidelines are fulfilled, a License to Import InVitro Diagnostic Device is granted by a regulatory authority.
Eligibility to Apply for InVitro Diagnostics Import License
In India, international manufacturers cannot straight apply as applicants. To submit their application for registration in the InVitro Diagnostic Import License, they have to appoint an Indian entity that is an authorised agent or license holder.
The authorized agent has either a manufacturing or wholesale license for distribution and sale for a grant of InVitro Diagnostics Import License can apply to the CDSCO. Through power of attorney, an authorised agent is any firm or organisation that an overseas manufacturer has appointed to undertake InVitro Diagnostic Devices import in India.
Forms Required for Application and Permission Of IVD Import License
- Form MD 14: Application for a Medical device import license for Class A, B, C and D IVD Diagnostic Devices.
- Form MD 15: Approval Form from central licensing agency to granting permission to import IVD Diagnostic kit by grant the license. CDSCO has the Authority to grant the license.
1. Covering Letter
- Specify whether the application is for new registration or re-registration.
- Include a list of enclosed documents.
- Must be signed by an authorized signatory.
2. Details of the Products to be Imported
- Complete list of In-Vitro Diagnostic devices with their category, intended use, and classification.
3. Details of the Manufacturing Site
- Name and address of the manufacturing facility.
- Manufacturing license or equivalent approval from the country of origin.
4. Regulatory & Legal Documents (As per Form MD-14)
- Power of Attorney (PoA) – Authorizing the Indian Agent (notarized & apostilled/legalized).
- ISO 13485 Certificate – Quality Management System certification.
- TR 6 Challan – Proof of fee payment.
- Good Manufacturing Practice (GMP) Certificate – As per WHO GMP or equivalent.
- CE Design Certificate – If applicable, for CE-marked devices.
- Declaration of Conformity – Stating compliance with safety & performance requirements.
- Post Market Surveillance (PMS) Report – If previously marketed.
- Business License/Plant Registration Certificate – Issued by the regulatory authority of the manufacturing country.
- Audit Report – Internal or external audit of the manufacturer’s facility.
- Constitution Details of the Indian Agent – Company registration documents, GST, PAN, etc.
- Wholesale or Manufacturing License of the Indian Agent – If applicable.
5. Quality & Compliance Certificates
- Free Sale Certificate (FSC) – Issued by the regulatory authority of the country of origin, ensuring the IVD devices are legally sold in that country.
- Quality Assurance Certificate – Issued by the overseas manufacturer, confirming product quality.
6. Plant Master File (PMF) – Mandatory for All IVD Devices
- Manufacturing Procedure Details – End-to-end production process.
- Source of Antigen/Antibody – Information on raw materials used.
- Characterization of Antigen/Antibody – Testing and validation reports.
- Detailed Composition of the IVD Device – List of all components.
- Medical Flowchart Process – Workflow and process validation.
- Batch Release Certificate – Manufacturer’s certificate for batch release.
- Detailed Test Report – Preclinical or clinical performance data.
Modifications & Additions For License Of Import For IVD Devices
- FSC is mandatory, but only for Class B, C, and D IVD devices as per CDSCO.
- GMP certificate must align with CDSCO/WHO GMP or equivalent standards.
- ISO 13485 certification is essential but should be up-to-date.
- Audit Report should be from an accredited body (internal/external).
- Post Market Surveillance (PMS) Report is needed for previously marketed devices.
Validity of Import License For InVitro Diagnostics Device
The Import License for IVD (MD-15) is valid for 5 Years from the date of issuance. When you obtain the license it shows that you comply with all the regulatory requirements.
What Are The Classification Criteria For IVD Devices in India?
The classification of the IVD medical devices are divided into four category as per their risk factors:
- Class A – Low risk (e.g., urine test strips)
- Class B – Low-Moderate risk (e.g., pregnancy test kits)
- Class C – Moderate-High risk (e.g., blood glucose monitors)
- Class D – High risk (e.g., HIV, HCV diagnostic kits)
Only Class B, C, and D IVD devices require an import license in India.
What are the Fees To Import License For InVitro Diagnostics Application?
The government fee for the registration of the license varies as per the device classification & the number of products included in the list. You can simply check the fee of registration on the CDSCO website or just make a call on number +91 9891 008 002.
How Long Does It Take to Obtain an IVD Import License From CDSCO?
The processing time to obtain the import license for Invitro diagnostics varies but typically it takes 3-6 months. Duration depends on the completeness of the application and whether any additional classification is required.
Can You Apply For IVD Medical Device Registration Online?
Yes, You can simply submit your application via the CDSCO SUGAM portal (https://cdscoonline.gov.in) using Form MD-14.
Is the Free Sale Certificate (FSC) mandatory for All IVD Devices?
Yes, a Free Sale Certificate (FSC) is mandatory for the Class B, C, and D IVD devices to ensure they are legally sold in their country of origin.
What Happens If Your Application Gets Rejected?
If your application got rejected due to omitted documents and non compliance, then an applicant must address the issues and reapply with corrections.
Can You Apply For Multiple IVD Devices in a Single Application?
Yes, a single Form MD-14 can cover multiple IVD devices, provided they are from the same manufacturer and belong to the same risk category.
