Get Free Expert Consultation
Get Free Expert Consultation
The InVitro Diagnostic Device Import License, regulated by the Central Drugs Standard Control Organisation under the Medical Device Rules, 2017, is mandatory for entities intending to import IVD medical devices into India. This includes reagents, kits, calibrators, controls, instruments, and software used for in-vitro examination of human specimens.
The import licensing process ensures that IVD devices comply with CDSCO-prescribed standards for safety, quality, performance, labelling, and risk-based classification. Partner with Corpbiz for end-to-end support, on-time coordination with CDSCO, and accurate regulatory documentation to obtain your IVD device import license.
The benefits of securing registration of import licenses for IVDs in India are as discussed below:
Obtaining registration for an import license for IVDs in India allows entities to legally import, sell, and distribute IVDs across Indian marketplaces.
Securing registration of import license for IVDs in India ensures compliance with India’s Medical Device Rules and Good Manufacturing Practices.
Securing InVitro Diagnostic Device Import License demonstrates a commitment to quality and safety, thereby building confidence among hospitals, labs, and patients.
Licensed importers gain a competitive advantage by meeting mandatory regulatory requirements, thereby enabling participation in government tenders, institutional procurement, and large diagnostic networks.
Regulatory scrutiny ensures that imported IVD devices meet safety, performance, and quality benchmarks, thereby reducing risks to patients and healthcare professionals. It is one of the benefits of InVitro Diagnostic Device Import License.
An In Vitro Diagnostic Device Import License helps prevent the circulation of counterfeit, misbranded, or substandard IVD products by ensuring traceability, proper labelling, and regulatory oversight.
Regulatory Strategy & Classification
The key eligibility criteria to obtain a CDSCO In-Vitro Medical Device Import license are as discussed below:
The applicants eligible to obtain an InVitro Diagnostic Device Import Permission are as follows:
The list of documents needed to obtain an import license for InVitro diagnostics devices in India is as follows:
The step-by-step process for obtaining an InVitro Diagnostic Device Import license in India is as follows:
Regulatory Strategy & Classification
Some of the important factors considered while applying for a medical device import license in India are as discussed below:
The applicants must ensure that a Free Sale Certificate issued by the National Regulatory Authority of the IMDRF group is available.
All manufacturing sites involved in the production of the IVD device must be clearly identified in the application
The power of attorney authorizing the Indian entity to act on behalf of the foreign manufacturer must be exactly in the format prescribed under the Medical Devices Rules, 2017.
All foreign documents must be duly notarized and apostilled in accordance with the requirements prescribed under the Medical Device Rules, 2017.
Applicants who do not have a predicate device must obtain CDSCO prior permission by filing Form MD-29 for import without permission.
All document formatting, which is part of the Device Master File, Plant Master File, and other technical documents, must strictly comply with the Medical Device Rules, 2017.
The application forms required to obtain an import license for InVitro diagnostics device are as provided below:
| Application From | Purpose | Approval License Form | Risk Class | Fees | Licensing Authority |
|---|---|---|---|---|---|
| MD-14 | It is an application for the issuance of an import license to import medical devices in Classes A and B. | Form MD-15 – License to Import Medical Device in Class A or B (In vitro) | Class A & B | $1000 per manufacturing site (plant) + $10 for the IVD product (per product) | CDSCO |
| MD-15 | It is an application for the issuance of an import license to import medical devices in Classes C and D. | Form MD-15 – License to Import Medical Device in Class C or D (In vitro) | Class C & D | $3000 per manufacturing site (plant) + $500 for the IVD product (per product) | CDSCO |
Get access to a nationwide network of 10,000+ regulatory, technical, legal, and medical device professionals having hands-on experience in CDSCO IVD import approvals.
Our structured regulatory methodology ensures 100% documentation accuracy, minimal deficiency queries, and faster processing for Invitro diagnostic device import registration.
Our specialised experts at Corpbiz hold in-depth knowledge of IVD risk classification, essential principles, ISO 13485, performance evaluation, and labelling requirements.
Corpbiz offers complete lifecycle support from regulatory pathway mapping and Form MD-14 filing to issuance of import license, amendments, retention, and post-approval compliance.
We help schedule personalised consultations with our CDSCO regulatory specialists to assess eligibility, documentation, applicable forms, and government fees for InVitro Diagnostic Device Import Registration.
With a strong PAN-India footprint, Corpbiz effectively coordinates with CDSCO and related authorities, ensuring smooth handling of IVD import approvals across India.
Corpbiz has successfully supported IVD licensing for Class A, B, C, and D devices, thereby maintaining a strong approval success rate across diverse diagnostic product categories.
Corpbiz, having 10+ years of experience in regulatory advisory, technical documentation, and licensing, is a trusted partner for medical device and IVD import licensing in India.
We at Corpbiz help importers optimise government fees and approval timeline by correctly mapping IVDs to Class A, B, C, and D, thereby preventing costly misclassification in India.
Legal Researcher
Written by Neha Dawra. Last updated on Jun 12 2026, 03:21 AM
Neha Dawra has 4+ years of experience in legal research and intellectual property advisory. Her expertise lies in analyzing IP laws, drafting structured legal content, and simplifying complex registration procedures into clear, simple insights.
Trusted by thousands of businesses across India for seamless compliance, registrations, and advisory services.
Really thankful to Corpbiz. Our experience with its expert was tremendous. Strong professional approach towards clients. My Company Registration was filed in a very less time, thanks to Corpbiz experts.
We would recommend Corpbiz incorporation services to any founder without a second doubt. The process was beyond efficient and shows Corpbiz founder's commitment and vision to truly help entrepreneurs and early stage startups to get them incorporated with ease.
I was searching for a company for assistance in the incorporation services. Then one of my friend tell me about Corpbiz and definitely the Corpbiz team is really efficient and has an experienced staff to guide us through the entire process of Company Incorporation.
Setting up our Bio Medical Waste Recycling Plant was a huge project. Mukul managed the entire compliance framework seamlessly from start to finish.
Corpbiz is very reliable and efficient. They managed all paperwork, resolved my queries, and completed my GST registration much quicker than I expected.