IVD Manufacturing Licence (MD-5 / MD-9)
Every in vitro diagnostic (IVD) kit, reagent or analyser made in India for sale needs a manufacturing licence under the Medical Devices Rules, 2017. Class A and B IVDs are licensed by the State Licensing Authority in Form MD-5; Class C and D by CDSCO in Form MD-9. We handle the classification, dossier, online filing and follow-up.
What it is
An IVD is a device or reagent used to test samples taken from the body, such as blood, urine or swabs. Rapid test kits, ELISA kits, blood-grouping reagents, specimen collection tubes and lab analysers are all IVDs. An IVD manufacturing licence is the permission to make them at a named site.
Take a Faridabad unit that makes blood-collection tubes and wants to add a rapid dengue test. The tubes and the test kit can fall in different classes. If the kit is Class C, the same factory deals with the State authority for one product and CDSCO for the other.
The law is the Drugs and Cosmetics Act, 1940 read with the Medical Devices Rules, 2017. Rule 4 sorts IVDs into four risk classes using the First Schedule, Part II: Class A (low risk), Class B (low-moderate), Class C (moderate-high) and Class D (high). The class decides who licenses you, which forms you file and how the site is checked. Licensing has applied to Class A and B IVDs since 1 October 2022 and to Class C and D since 1 October 2023.
Who it applies to
You make kits or reagents
Units making rapid tests, ELISA kits, clinical chemistry reagents, controls and calibrators, whatever their size.
You make analysers or consumables
Makers of analysers, specimen collection tubes, buffers and washing solutions. Many of these fall in Class A.
You sell under your own brand
A diagnostics startup that gets its kits made at another licensed site applies for a loan licence: Form MD-4 for Class A/B, Form MD-8 for Class C/D.
Class decides the route
| Class | Licensing authority | Apply in | Licence | Site check |
|---|---|---|---|---|
| A | State Licensing Authority | MD-3 (loan MD-4) | MD-5 (loan MD-6) | No audit before grant; notified body audit within 120 days after grant |
| B | State Licensing Authority | MD-3 (loan MD-4) | MD-5 (loan MD-6) | Notified body audit within 90 days of application |
| C and D | Central Licensing Authority (CDSCO) | MD-7 (loan MD-8) | MD-9 (loan MD-10) | Inspection within 60 days of application |
Why it matters
Legal manufacture and sale
Since the licensing dates, no IVD of any class can be made for sale without a licence. A buyer checking your paperwork will ask for the MD-5 or MD-9 first.
Product-wise approval
The licence lists each product. Launch a new kit without adding it first, and that kit is unlicensed, even if the rest of your range is fine.
Valid in perpetuity
Under Rule 29, the licence stays valid as long as the retention fee is paid before each five-year period ends.
Documents required
About the company and site
- Constitution documents (for example, a private limited company’s MOA and AOA) and details of directors or partners
- Ownership or rent documents for the premises
- Site layout and list of equipment
- Plant Master File
About the products
- Device Master File for each IVD
- Classification of each product
- Labels and instructions for use
- Performance evaluation data where required
About people and quality
- Qualification and experience of technical staff
- Quality management system documents under the Fifth Schedule (ISO certification, if held, is useful supporting evidence)
- Fee payment proof
How it works
Classify each product
We map every kit and reagent to Class A, B, C or D using the First Schedule and the CDSCO classification list. This fixes the authority and forms.
Assemble the master files
Your technical team and consultants prepare the Plant Master File, Device Master Files and quality system. We check them against the Rules and flag gaps in format. In practice, this step takes the longest.
File the application online
We file Form MD-3 or MD-7 on the online system for medical devices (cdscomdonline.gov.in) and pay the fee.
Clear the audit or inspection
A registered notified body audits Class A and B sites; CDSCO inspects Class C and D sites. We coordinate dates and help answer observations until the licence is issued.
Timelines
Class A
Licence within 45 days of application, without a prior audit. A notified body audits the site within 120 days of the grant.
Class B
Notified body audit within 90 days of application; licence within 20 days of the audit report.
Class C and D
Inspection within 60 days of application; licence within 45 days of receiving the inspection report.
What happens if you miss the retention fee
Late fee
Under Rule 29, a late fee of 2% of the retention fee applies for every month of delay.
Cancellation
Here is the catch: if the fee stays unpaid beyond 180 days, the licence is cancelled.
Production stops
Without a licence, kits cannot be made or sold. Getting back means a fresh application, a fresh fee and a fresh audit or inspection, while orders wait.
Frequently asked questions
How do I know the class of my IVD?
Classification follows Rule 4 and Part II of the First Schedule to the Medical Devices Rules, 2017, which grade IVDs by risk. CDSCO also publishes a classification list. Specimen tubes and buffers usually sit in Class A, while HIV, HBsAg and HCV tests used for blood screening are Class D. We check each product before you file.
Who licenses Class A and B IVDs in Haryana?
The State Licensing Authority, which in Haryana is the State Drugs Controller under the Food and Drugs Administration. Class A and B applications go to the State authority with jurisdiction over the manufacturing site. Class C and D applications go to the Central Licensing Authority at CDSCO, handled through its zonal or sub-zonal office.
What is the government fee for an IVD manufacturing licence?
For Class A and B, the fee is ₹5,000 per site plus ₹500 per product. For Class C and D, it is ₹50,000 per site plus ₹1,000 per product. A retention fee is payable every five years to keep the licence alive. We calculate the exact figure from your product list before filing.
What is a notified body?
A notified body is a third-party conformity assessment body registered with CDSCO. For Class B, it audits your site within 90 days of application; for Class A, within 120 days after the licence is granted. The audit is done by the notified body, not by us. We help you pick one and prepare documents.
Do new IVDs need performance evaluation?
Yes, for new Class B, C and D IVDs. CDSCO’s guidance asks for performance evaluation on three independent batches before the product is licensed. The evaluation is done by designated laboratories. To make these trial batches, you first take a test licence in Form MD-13, applied for in Form MD-12. We can file that too.
What is a test licence and how long is it valid?
A test licence lets you make small quantities for clinical investigation, test or evaluation. You apply in Form MD-12 and the licence is granted in Form MD-13, within 30 days under Rule 31. It is valid for three years. First-time manufacturers of a new kit often start here, make the trial batches, and then apply for the full licence.
What qualifications must technical staff have?
The person supervising manufacture needs a degree in engineering or pharmacy with at least two years’ experience in manufacturing or testing of devices, or a diploma in engineering or pharmacy with at least four years. Testing is supervised by a similarly qualified person with testing experience. We check the certificates and experience letters against the Rules before filing.
Does the licence need renewal?
No renewal is needed. Under Rule 29, MD-5, MD-6, MD-9 and MD-10 licences stay valid in perpetuity if the retention fee is paid before each five-year period ends. Late payment attracts 2% per month, and the licence is cancelled if the fee stays unpaid beyond 180 days. We keep the date on our calendar.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fee for the manufacturing licence: Class A and B, ₹5,000 per site and ₹500 per product; Class C and D, ₹50,000 per site and ₹1,000 per product. Notified body audit charges are paid directly to the notified body.
Ready to begin?
Share your product list and site address. We will classify each IVD and show you which authority, forms and fees apply.