Medical device registration in India means obtaining a manufacturing or import licence for your device under the Medical Devices Rules, 2017 (MDR 2017), which are framed under the Drugs and Cosmetics Act, 1940. Which licence you need depends on the risk class of the device (A, B, C or D) and on whether you manufacture in India or import. This page explains the classification, the forms, the documents, the authorities involved and the practical points that decide whether an application moves smoothly or is sent back with queries.
What is medical device registration under MDR 2017?
Before 2018 only a short list of devices was licensed in India, and the rest were sold without a specific approval. The Medical Devices Rules, 2017 changed this by creating a complete regulatory regime for all medical devices. Devices are now notified as drugs under the Drugs and Cosmetics Act, and every device is covered by a risk-based rule set that governs manufacture, import, sale, clinical investigation, labelling and post-market obligations. The rules were brought in on a phased basis, so that Class A and B devices and then Class C and D devices became subject to mandatory licensing in stages.
The core idea is risk classification. Class A is low risk (for example a simple thermometer), Class B is low to moderate risk (for example needles or suction cannulas), Class C is moderate to high risk and Class D is high risk, such as implantable and life-supporting devices. The class decides who grants the licence, the form you use, the audit that the site undergoes and the technical file you must submit. CDSCO publishes classification lists device by device, and where your product is not listed you need to check the classification rules in the Second Schedule or seek classification from the authority.
Two licensing tracks exist for Indian manufacturers. For Class A and B devices you apply on Form MD-3 to the State Licensing Authority, and the licence is issued on Form MD-5 after a Notified Body audit of the manufacturing site. For Class C and D devices you apply on Form MD-7 to the Central Licensing Authority at CDSCO, and the licence is issued on Form MD-9 after review of the application and an inspection or audit. Importers apply on Form MD-14 to CDSCO and receive an import licence on Form MD-15, with an authorised agent in India responsible for the product.
A device licence is not the same as an approval of clinical efficacy. It confirms that the manufacturing quality system, the device's technical documentation and its labelling meet the Rules for the class. Many applicants also discover that the same product may need other approvals, such as BIS certification for certain products or an AERB approval for radiation-emitting equipment, which sit outside MDR 2017.
Who needs a medical device licence?
Anyone who manufactures or imports a medical device for sale or distribution in India falls within MDR 2017. Typical applicants include:
- Indian manufacturers of Class A and B devices such as syringes, gloves, dressings, diagnostic strips, thermometers and basic instruments
- Indian manufacturers of Class C and D devices such as ventilators, infusion pumps, implants, stents and in-vitro diagnostic kits for serious conditions
- Importers of finished medical devices, including trading companies and Indian subsidiaries of foreign manufacturers
- Foreign manufacturers who sell into India through an authorised agent
- Contract manufacturers and loan licence holders producing devices for a brand owner
- Start-ups and R&D companies commercialising a new device and planning clinical investigation or testing
- Distributors and hospitals that need to verify that the device they buy carries a valid licence
Benefits of Medical Device Registration (CDSCO)
Lawful market access
A valid manufacturing or import licence lets you sell to hospitals, distributors and government buyers, which routinely ask for the licence copy and the product list.
Tender and empanelment eligibility
Public procurement and large hospital chains ask for device licence details before they will list a supplier.
Quality system discipline
Building the quality management system and technical file required by the Rules gives you a documented process that supports audits, customer queries and later certifications.
Clear accountability
The Rules place responsibility on the licence holder for complaints, recalls and vigilance, which helps you manage product risk before it becomes a legal problem.
Export readiness
A documented quality system and a licensed Indian site are a useful base when buyers or foreign regulators ask for evidence of regulatory compliance.
Eligibility and applicability
MDR 2017 does not restrict who may apply by qualification in the way a pharmacy licence does, but it requires the applicant to have the capability to manufacture and control quality.
- A legally constituted entity such as a company, LLP, partnership or proprietorship with a defined authorised signatory
- Manufacturing premises with adequate space, utilities and controlled areas that meet the Fifth Schedule requirements for the class of device
- A quality management system aligned to the Rules and, in practice, to ISO 13485 for most manufacturers
- Competent technical staff for manufacture and quality control, named in the application
- A Device Master File and Plant Master File prepared as required by the Fourth Schedule
- For importers, an authorised agent in India who holds the required wholesale or sale licence and a manufacturer's authorisation to act for the foreign site
- Devices must be correctly classified, and any change of class or intended use needs a fresh look at the licence
Documents required
Applicant and entity documents
- Constitution documents: certificate of incorporation, partnership deed or proprietorship proof, with authorisation of the signatory
- PAN and GST registration of the entity, and identity and address proof of directors or partners
- Undertaking in the prescribed form signed by the applicant, as required by the Rules
- Power of attorney or manufacturer's authorisation for importers acting for a foreign manufacturer
Premises and quality system documents
- Proof of ownership or lease of the manufacturing premises, site plan and layout of production, storage and quality control areas
- Plant Master File describing the site, equipment, utilities, personnel and quality arrangements
- Quality manual, standard operating procedures and, where available, ISO 13485 certificate
- List of equipment, test instruments and calibration records
- Pollution control consent or NOC, where applicable to the manufacturing activity
Product and technical documents
- Device Master File with device description, intended use, design, materials, specifications and manufacturing process
- Essential Principles checklist and risk management file
- Test reports, biocompatibility, sterilisation and stability data where applicable to the device
- Labels and instructions for use meeting the labelling rules of MDR 2017
- For Class C and D, clinical evidence or performance evaluation as the Rules require, and for imports the free sale certificate and quality system certificate of the foreign site
Step-by-step process
The sequence below describes a typical manufacturing application. Imports follow a similar logic with CDSCO as the single authority.
Classify the device
Match your device to the CDSCO classification lists or the Second Schedule. The class decides the authority, form and audit. Record the reasoning, because an incorrect class is the commonest cause of a rejected file.
Build the quality system and technical file
Prepare the Plant Master File, Device Master File, risk management documents, specifications and labels. Align your procedures with the Fifth Schedule requirements before you file.
Register on the portal
Create the login on CDSCO's licensing system (SUGAM) or the State portal, upload the entity details and prepare the digital signature that the portal requires for the authorised signatory.
File the application and pay the fee
File Form MD-3 with the State Licensing Authority for Class A and B, or Form MD-7 with CDSCO for Class C and D. Pay the per-site and per-device government fee online or by challan as the portal directs.
Scrutiny and queries
The authority checks the file for completeness and consistency. Expect queries on classification, documents or the quality system and respond with a covering letter that points to the exact document or page.
Audit or inspection
For Class A and B, a Notified Body audits the manufacturing site and reports to the State Licensing Authority. For Class C and D, CDSCO conducts or arranges an inspection. Close every observation in writing.
Grant of licence
On satisfactory completion the authority grants the licence on Form MD-5 (Class A and B) or Form MD-9 (Class C and D). Check the device names, class, site address and conditions printed on the licence.
Start commercial activity and maintain compliance
Label devices as per the Rules, set up a complaint and recall procedure, and put the retention fee date on your compliance calendar.
Government fees
MDR 2017 charges a fee per manufacturing site and a further fee per device, with different amounts by class and for manufacture versus import. Import fees are charged in US dollars for foreign sites. Always check the Fourth and Seventh Schedule fee table, or the portal's fee calculator, on the date of filing.
| Item | Amount | Note |
|---|---|---|
| Class A or B manufacturing licence (MD-3 application) | ₹5,000 per site plus ₹500 per device | As reported by a regulatory consultancy; confirm in the Rules before payment. |
| Class C and D manufacturing licence (MD-7 application) | Per site and per device fee as per the Rules | Higher than Class A and B; verify the exact amount in the schedule. |
| Import licence (MD-14 application) | Per site and per device fee as per the Rules | Charged in US dollars for the foreign manufacturing site. |
| Retention (renewal) fee | As per the Rules, every five years | Payable within the prescribed period to keep the licence in force. |
Professional charges are quoted separately after reviewing your case. Government fees are paid directly to the authority.
How long does it take?
Medical device licensing is document and audit driven, so the timeline depends on the quality of your file and on how quickly you close observations. A consultancy source describes about four to five months for a Class A or B manufacturing licence, but this is an indication, not a legal period, and Class C and D and imports usually take longer. We do not promise a fixed government timeline.
| Stage | Typical time |
|---|---|
| Classification, quality system and technical file preparation | Depends on how mature your documents are |
| Scrutiny of application and query rounds | Varies with queries and responses |
| Notified Body or CDSCO audit and closure of observations | Depends on audit scheduling and the nature of observations |
| Grant of licence | After satisfactory audit |
Validity and renewal
The manufacturing licence under MDR 2017 remains in force perpetually, provided you pay the retention fee within five years of grant and each five-year block thereafter, and continue to comply with the conditions. The authority can suspend or cancel the licence for non-compliance, such as selling a device outside the licensed class or failing to act on a serious complaint. Changes to the device list, site, constitution or key personnel need prior approval or notification in the form required by the Rules, so do not change the site or add a device without checking.
Compliance after approval
- Display the licence at the premises and quote the licence number on labels and invoices as the Rules require
- Maintain batch manufacturing and distribution records, and keep devices traceable to the batch
- Run a documented complaint handling, field safety corrective action and recall procedure
- Report serious incidents and adverse events to the authority within the prescribed period
- Keep labels and instructions for use consistent with the licence and the Rules
- Pay the retention fee on time and seek approval before adding devices, changing site or ownership
- Cooperate with surveillance inspections and keep audit observations closed with evidence
Route by risk class
| Class A and B manufacture | Class C and D manufacture | Import |
|---|---|---|
| Authority: State Licensing Authority | Authority: CDSCO (Central Licensing Authority) | Authority: CDSCO |
| Application: Form MD-3 | Application: Form MD-7 | Application: Form MD-14 |
| Licence: Form MD-5 | Licence: Form MD-9 | Licence: Form MD-15 |
| Site audit by a Notified Body | Inspection or audit led by CDSCO | Foreign site quality system evidence and Indian agent |
| Fee in rupees per site and device | Fee in rupees per site and device | Fee in US dollars per site and device |
Common mistakes and rejection reasons
Wrong classification
Treating a Class B device as Class A, or the reverse, sends the file to the wrong authority or gets it returned. Classify against the official lists and keep the rationale on file.
Thin quality system
A generic quality manual copied from a template, with procedures that the site does not actually follow, is exposed at the audit. Build procedures from what the plant does.
Inconsistent product details
Device names, models and intended use differ between the application, the labels and the test reports. Use one master product sheet.
Missing or weak test evidence
Sterility, biocompatibility, electrical safety or performance reports that are old, unsigned or not mapped to the device variant lead to repeated queries.
Import file gaps
Unauthenticated free sale certificates, expired quality system certificates of the foreign site, or an authorised agent without the right licence stall import applications.
Ignoring other approvals
Founders assume the device licence is the only approval and later find that BIS, AERB, pollution consent or a drug licence for the sale side is also needed.
Penalties for non-compliance
Manufacturing, importing or selling a medical device without the required licence, or selling a substandard or misbranded device, is an offence under the Drugs and Cosmetics Act, 1940 read with MDR 2017. Penalties include imprisonment and fine, and the authority may also suspend or cancel the licence and order a recall. We have not listed section-wise penalty amounts here because they depend on the nature of the offence and the Act as amended; take the current text from India Code before advising on a specific case.
Practitioner tips
- Spend the first week on classification and intended use. Everything else, from the authority to the fee, follows from them, and a rewrite of the intended-use statement later changes the class.
- Write the Plant Master File and procedures after walking the shop floor with the production and quality heads. Auditors ask staff to describe a procedure, and answers must match the document.
- For imports, get the foreign manufacturer's authorisation, quality certificate and free sale certificate checked for validity and authentication before you start the online form.
- Keep a single device matrix listing each model, variant, class, test report reference and label file. Fees are charged per device, so the matrix also helps you control cost.
- If you also sell the device through your own shop or distribution, check whether a drug licence for the sale side is needed for your state.
How Lawgical Guru helps
Classification and route advice
We review your device, intended use and the CDSCO lists to identify the likely class and whether you need a manufacturing, loan or import licence.
Gap review of documents
We check your Plant Master File, Device Master File, labels and test evidence against the requirements and list what to fix before filing.
Portal filing
We prepare the application, upload the documents and pay the fee through the relevant portal for the licence route you need.
Query and audit support
We help draft replies to authority queries and prepare an audit readiness checklist for the Notified Body or CDSCO visit.
Linked registrations
We support GST registration, IEC, BIS certification and a drug licence where your business needs them.
Medical Device Registration (CDSCO): frequently asked questions
Is medical device registration mandatory in India?
Yes. Under the Medical Devices Rules, 2017, every medical device that is manufactured or imported for sale must be covered by a licence from the relevant authority. Licensing was phased in by class, and all classes are now within the regime. Check the CDSCO notification for your device before selling.
Which authority issues the licence for Class A and B devices?
The State Licensing Authority, usually the State Drugs Control Department, grants the manufacturing licence for Class A and B devices on Form MD-5 after a Notified Body audit. Class C and D manufacture and all imports are handled by the Central Licensing Authority at CDSCO.
What is the difference between MD-5 and MD-9?
Form MD-5 is the manufacturing licence for Class A and B devices issued by the State Licensing Authority. Form MD-9 is the manufacturing licence for Class C and D devices issued by CDSCO. The corresponding application forms are MD-3 and MD-7 respectively.
How do I find the class of my device?
Check the CDSCO classification lists, which classify many devices by name, and the classification rules in the Second Schedule of MDR 2017. If the device is not listed, document your reasoning from intended use, invasiveness and duration of contact, and seek confirmation from the authority.
Do I need ISO 13485 to get a licence?
The Rules require a quality management system for manufacture, and ISO 13485 is the standard most manufacturers use to meet it. The Rules themselves set the requirements in the Fifth Schedule, so confirm what your class requires. ISO 13485 certification is also commonly asked for by importers and buyers.
Can I import medical devices without an Indian entity?
A foreign manufacturer must appoint an authorised agent in India who applies for the import licence and takes responsibility under the Rules. The agent needs the correct licence for sale or distribution and a valid authorisation from the manufacturer for the specific devices.
Does the licence expire?
A manufacturing licence under MDR 2017 does not have an expiry date if the retention fee is paid within the prescribed period, which is every five years from grant. Non-payment or breach of conditions can lead to suspension or cancellation by the authority.
How much does medical device registration cost?
Government fees depend on the class, the number of sites and the number of devices. For Class A and B manufacture a consultancy source reports ₹5,000 per site and ₹500 per device. Class C and D and import fees are higher, and import fees are charged in US dollars. Professional charges are separate.
Is a medical device licence the same as CE marking or FDA approval?
No. A CDSCO licence is the Indian regulatory permission. CE marking and US FDA clearance are separate approvals for the European and US markets. Evidence prepared for one, such as ISO 13485 or test reports, can support the others, but each regulator issues its own approval.
Do hospitals and clinics need a medical device licence?
A hospital that only uses devices does not need a manufacturing or import licence. A hospital that manufactures, imports or sells devices does. Hospitals should still buy only licensed devices and keep the supplier's licence copy on file.
Reviewed by Satyam Gupta, Company Secretary (CS) & Advocate
8+ years of industry experience. This page was last reviewed on 16 October 2026 against the official sources below. Rules and fees change — confirm on the official portal before you apply.