Medical Device Manufacturing License in India: Class A to D, MD-5 and MD-9

A Medical Device Manufacturing License in India, Matched to Your Device's Risk Class

A medical device manufacturing license is the permission, granted under the Medical Devices Rules, 2017, to manufacture medical devices or in-vitro diagnostic (IVD) devices for sale or distribution. Since 1 October 2023, every class of medical device manufactured in India has needed a license, except non-sterile, non-measuring Class A devices, which now need only a registration number. The license you need, the authority that grants it, and the audit you face all depend on your device's risk class.

For medical device manufacturers in India, that means two different routes. Class A and Class B devices are licensed by the State Drug Licensing Authority on Form MD-5, with a notified body audit. Class C and Class D devices are licensed by CDSCO, the Central Licensing Authority, on Form MD-9, after an inspection. Every application is filed online on ONDLS or your state drug licensing portal.

Regovex Consulting is a CDSCO registration consultant and drug regulatory consultant in India with a dedicated medical device practice. We confirm each device's class against CDSCO's published classification lists, prepare the Device Master File and Plant Master File, build or review your quality management system under the Fifth Schedule, file the application, and prepare your team for the audit or inspection. Medical device companies that outsource manufacturing get the same support for loan licenses and contract arrangements.

Who Needs a Medical Device Manufacturing License in India?

Any business that manufactures a medical device or IVD for sale or distribution needs a license for each manufacturing site. In India, that includes:

• Medical device manufacturers making disposables, implants, instruments, equipment or diagnostic kits
• Start-ups and medical device companies moving from prototype to commercial production
• Brand owners who manufacture in another company's licensed site under a loan license
• Contract manufacturers making devices for other brands
• IVD manufacturers making reagents, test kits and analysers
• Existing licensees adding new devices, a new site or a higher-risk class
• Makers of non-sterile, non-measuring Class A devices, who need a registration number instead of a license

If you import devices rather than make them, you need a CDSCO import license instead; see our medical device import license service.

Medical Device Risk Classes A, B, C and D: Which License Applies?

The Medical Devices Rules, 2017 group devices into four classes by risk to the patient and user. The class decides who licenses you, which form you use, and whether you face a notified body audit or a CDSCO inspection. Getting it wrong means filing with the wrong authority.

CDSCO publishes risk classification lists for devices and IVDs by category. Regovex checks each device against the current list before any document is prepared, and where a device is not listed, applies the classification rules in the First Schedule. For a fuller guide to classification and the CDSCO medical device system, see our medical device registration hub.

CDSCO medical device classification: how to find your device's class

CDSCO medical device classification decides everything that follows: the authority, the form, the audit and the fee. CDSCO publishes lists that place notified medical devices and IVDs into Class A, B, C or D, grouped by category such as cardiovascular, orthopaedic, dental, ophthalmic, anaesthesiology, urology and in-vitro diagnostics. To classify a device:

1. Define the intended use exactly as it will appear on the label and instructions for use.
2. Search CDSCO's classification list for the device's category and generic name.
3. If listed, use that class, and note any sub-type, such as sterile or measuring versions, that changes it.
4. If not listed, apply the classification rules in the First Schedule of the Medical Devices Rules, 2017, considering invasiveness, duration of contact, whether the device is active, and whether it is implantable or contains a drug.
5. For IVDs, apply the separate IVD rules, which look at the risk to the patient and to public health from a wrong result.
6. Where two rules apply, the higher class applies.
7. Record the reasoning in the Device Master File, because the licensing authority and notified body will check it.

A wrong class is the most expensive mistake in medical device licensing: a Class C device filed as Class B goes to the wrong authority, and the file has to start again. Regovex confirms the class of every device in writing before any document is prepared.

Medical Device Manufacturing License Forms: MD-5, MD-6, MD-9, MD-10 and More

MD-5 license for Class A and Class B devices

The MD-5 license is the state-level medical device manufacturing license. For Class A, the State Licensing Authority decides within 45 days of the application, without a prior audit, and a notified body audits the site within 120 days after the license is granted. For Class B, a notified body audits the site within 90 days of the application, reports within 30 days, and the state decides within 20 days of receiving the audit report.

MD-9 license for Class C and Class D devices

The MD-9 license is granted centrally. CDSCO scrutinises the application, inspects the site within 60 days of the application through a team of medical device officers (or a notified body), and decides within 45 days of receiving the inspection report. Class C and D applications need the most complete technical files, including performance and safety data for the device.

Test license (MD-13): issued by CDSCO, even for Class A and B

A test license lets you make small quantities of a device for clinical investigation, test, evaluation, demonstration or training before commercial licensing. The application goes to the Central Licensing Authority on Form MD-12, and the license is granted on Form MD-13 within 30 days. It is valid for three years. This applies to every class, so a Class A or B manufacturer applies to CDSCO for a test license, not to the state.

Non-sterile, non-measuring Class A devices: registration instead of a license

CDSCO has published a list of Class A devices that are non-sterile and non-measuring. These are exempt from the manufacturing license chapters of the rules, provided the manufacturer obtains a registration number through the CDSCO online system. If the same device is supplied sterile or has a measuring function, it needs a normal license. We check your device against the current list, which CDSCO revises from time to time.

Medical device license at a glance

A medical device license is the general name people use for any of these approvals. For manufacturers, it means MD-5 or MD-6 from the state for Class A and B, or MD-9 or MD-10 from CDSCO for Class C and D. Sellers need an MD-42 registration, importers an MD-15 import licence, and developers an MD-13 test licence. Most medical device companies need more than one: for example, a manufacturer that also sells directly needs its manufacturing licence and a state sale registration for any separate warehouse.

Eligibility for a Medical Device Manufacturing License in India

The licensing authority grants a medical device manufacturing license to a site that can show four things:

1. A quality management system that meets the Fifth Schedule of the Medical Devices Rules. The Fifth Schedule closely follows the ISO 13485 standard, and manufacturers of Class B, C and D devices give a signed undertaking of compliance with it.
2. Competent technical staff working full-time, qualified and experienced in manufacturing or testing medical devices.
3. A suitable site and infrastructure for the device: controlled areas or clean rooms for sterile devices, sterilisation arrangements, utilities and storage.
4. Testing capability, either in-house or through an arrangement with a laboratory, to test incoming materials, in-process items and finished devices.

Technical staff for a medical device manufacturing license

The rules require competent technical staff for manufacture and for testing. Qualifications typically accepted are:

The exact qualification and years of experience are set in Rule 22 and depend on the device. Experience certificates should show work on medical devices specifically. We verify each person's documents before they are named in the application.

The Fifth Schedule quality management system

A Fifth Schedule QMS is the backbone of every medical device license. Auditors and inspectors check that it is documented, implemented and working. It typically covers:

• A quality manual, quality policy and management responsibility
• Document and record control
• Design and development controls, for manufacturers who design their devices
• Purchasing controls and supplier evaluation
• Production and process controls, including validation of special processes such as sterilisation, sealing and moulding
• Identification and traceability of each device and batch
• Monitoring and measurement, including inspection and testing of finished devices
• Control of non-conforming product, corrective and preventive action (CAPA) and internal audits
• Complaint handling, adverse event reporting and recalls

If you already hold ISO 13485 certification, much of this is in place, but it still has to be aligned with the Indian rules, labelling and reporting requirements.

Documents Required: Device Master File, Plant Master File and More

Every medical device manufacturing license application is built around two technical files.

Device Master File (DMF)

The Device Master File describes each device or device group: its description and intended use, classification, design and materials, specifications, manufacturing process, labelling, risk management, verification and validation (including sterilisation and biocompatibility where relevant), and post-market data. For Class C and D devices, it also carries clinical or performance evidence. Inconsistencies between the DMF, labels and test reports are the most common reason for queries.

Plant Master File (PMF)

The Plant Master File describes the site: the company and its personnel, the premises and layout, environmental controls, utilities, equipment, the quality system, production and quality control arrangements, storage, and handling of complaints and recalls. It must match the site the auditor will see.

Other documents

• Proof of constitution of the company and identity of directors or partners
• Ownership deed or lease of the site, and site and layout plans
• Technical staff qualifications, experience certificates and appointment letters
• Undertaking of compliance with the Fifth Schedule, where required
• Test reports and, where relevant, sterilisation validation and biocompatibility reports
• Labels and instructions for use
• ISO 13485 certificate, if held
• For a loan license, the agreement with the host site and its license

Regovex writes or reviews the Device Master File and Plant Master File for each client, so the technical story is consistent across every document before it reaches the auditor.

Sterile Devices and IVDs: What Changes in the License File

Sterile medical devices

A device supplied sterile carries more risk than the same device supplied non-sterile, and the license file has to prove sterility. For sterile devices, auditors and inspectors expect:

• Validated sterilisation: ethylene oxide, gamma irradiation, steam or another method, validated for the device and its packaging, whether done in-house or by a contract steriliser
• Controlled manufacturing areas: clean rooms or controlled zones for assembly and packing, with environmental monitoring
• Packaging validation: evidence that the sterile barrier stays intact for the full shelf life
• Residue and bioburden control: for example, ethylene oxide residue testing where that method is used
• Shelf-life evidence: real-time or accelerated ageing data supporting the expiry date on the label

A device that is otherwise Class A loses the non-sterile, non-measuring exemption the moment it is supplied sterile, so it needs a full MD-5 license.

In-vitro diagnostic (IVD) devices

IVD reagents, kits and analysers follow the same Medical Devices Rules, with their own risk classification by the purpose of the test and the impact of a wrong result. Their Device Master File is built around performance evaluation rather than clinical data: sensitivity, specificity, precision, stability of reagents and kit components, and lot-to-lot consistency. Higher-risk IVDs, such as those for blood screening, are Class D and need a CDSCO MD-9 license, and some may need evaluation at a CDSCO-notified laboratory. Regovex plans performance evaluation early, because it is often the longest step in an IVD file.

How to Get a Medical Device Manufacturing License in India: Step-by-Step

The route depends on the class, but every medical device manufacturing license in India follows the same core steps: classify, build the quality system and technical files, apply online, pass the audit or inspection, and receive the license.

1. Classify each device against CDSCO's lists and the First Schedule rules, and check whether a Class A device is on the non-sterile, non-measuring list.
2. Plan the license route: MD-5 or MD-6 from the state for Class A and B, MD-9 or MD-10 from CDSCO for Class C and D, and a test license on MD-13 if you need samples first.
3. Prepare the site and QMS to the Fifth Schedule, including process validation and testing.
4. Write the Device Master File and Plant Master File and collect the supporting documents.
5. Apply on ONDLS or your state drug licensing portal on Form MD-3, MD-4, MD-7 or MD-8, with the fee.
6. Audit or inspection: a notified body audit for Class A (after grant) and Class B (before grant), or a CDSCO inspection for Class C and D.
7. Close observations with a clear compliance report and evidence.
8. Grant of the license on MD-5, MD-6, MD-9 or MD-10, listing the approved devices.

Timelines by class, as set in the rules

These are the timelines in the Medical Devices Rules, 2017. Real timelines also depend on how complete the file is and how quickly observations are closed, which is where preparation pays off.

What to have ready before you apply, by class

Because Class A licenses are decided before the audit, Class A manufacturers sometimes start production with a QMS that is not yet working. The post-grant audit will find that, so treat the 120 days as time to prove the system, not to build it.

Government fees

Where a site makes devices of more than one class, the fee for the higher class applies. Regovex quotes its professional fee in writing after the free classification check, with government and notified body fees shown separately.

What auditors and inspectors check

• The site matches the Plant Master File, with controlled areas suited to each device
• The QMS is implemented, with records, not just procedures
• Process validation for special processes such as sterilisation, sealing and moulding
• Calibration and maintenance of equipment and test instruments
• Traceability from raw material to finished device
• Testing of finished devices against specifications
• Labels and instructions for use matching the Device Master File
• Competent technical staff present and able to explain the process

Common reasons for delay

• A device filed under the wrong class or with the wrong authority
• Device Master File, labels and test reports that do not agree with each other
• Sterilisation or biocompatibility validation not complete at audit
• A QMS that exists on paper but has no records
• Technical staff without medical device experience
• Slow or incomplete responses to audit observations

Notified Bodies for Class A and B Audits: How They Fit In

A notified body is an independent conformity assessment body registered with CDSCO to audit medical device manufacturing sites. For Class A and B licenses, the state relies on the notified body's audit report: after grant for Class A, and before grant for Class B. For Class C and D, CDSCO may also use a notified body for inspection.

When choosing a notified body:

• Confirm it is currently registered with CDSCO for the device categories you make
• Ask for its audit fee, audit duration and availability against the 90-day window for Class B
• Share your Plant Master File and QMS documents before the audit, so the audit plan matches your site
• Plan who from your team will attend and answer for each process

Regovex coordinates with the notified body on your behalf, prepares your team, and drafts the responses to any non-conformities raised.

Setting Up a New Medical Device Unit in India: Other Approvals

The medical device license is the core approval, but a new site usually needs these too:

Regovex plans the medical device license alongside these approvals and your construction schedule, so the site is ready for audit when the equipment is installed.

Medical Device Companies and Contract Manufacturing: Loan Licenses Done Right

Many medical device companies in India design and sell devices but do not own a plant. They work with contract manufacturers, which is legal and common, but the license has to be set up correctly.

Under either route, the device must be on a valid license before commercial manufacture, and labels must show the actual manufacturing site and license number.

How to choose medical device manufacturers for contract production

Before signing with any of the medical device manufacturers you are considering, check:

1. License class: a current MD-5 or MD-9 that covers your device's class and type
2. Your device on the license: or a clear plan and timeline to add it
3. QMS and audit history: the latest notified body or CDSCO audit outcome, and ISO 13485 status
4. Special processes: validated sterilisation, cleanroom class and packaging validation suitable for your device
5. Testing: in-house or contracted testing for your device's standards
6. Quality agreement: who owns the design, the Device Master File, complaints, adverse event reporting and recalls
7. Retention fee: proof the license is current

Regovex reviews contract manufacturers' licenses and agreements for medical device companies and files loan licenses where that route suits you better.

Medical Device License Retention Fee and Changes

Under Rule 29 of the Medical Devices Rules, a manufacturing license remains valid in perpetuity, unless suspended or cancelled, if the retention fee set in the Second Schedule is paid before five years from the date of issue, and every five years after that. A late payment attracts a late fee of 2% of the retention fee for each month or part of a month; if it is not paid within 180 days, the license is cancelled.

During the license period, changes must be handled properly:

• Major changes, such as to the device design, materials, intended use, manufacturing site or sterilisation method, need prior approval of the licensing authority
• Minor changes, such as some administrative details, need to be informed to the authority within the time allowed
• New devices must be added to the license before manufacture
• A new site needs its own license
• Change of technical staff or constitution must be reported

Compliance After You Get Your Medical Device Manufacturing License

Medical device licensing does not end at grant. Manufacturers in India must keep the quality system running and report on their devices in the market:

• Batch and device records with full traceability
• Labelling as required by the rules, including the license number, batch or serial number, manufacturing and expiry dates where applicable, and instructions for use
• Complaint handling and adverse event reporting to the authorities under the materiovigilance system
• Field safety corrective actions and recalls under written procedures
• Internal audits and management reviews under the Fifth Schedule
• Periodic audits or inspections by the notified body, state or CDSCO
• Retention fee paid on time

Regovex supports post-approval compliance with QMS reviews, mock audits, and help with adverse event and recall procedures.

Medical device labelling: get it right before the first batch

Labels and instructions for use are part of the Device Master File, and auditors compare them with it. Under the Medical Devices Rules, device labels generally need to show:

• The name of the device and details needed to identify it and its use
• The name and address of the manufacturer and the manufacturing site
• The manufacturing license number
• The batch, lot or serial number
• The date of manufacture and, where applicable, the expiry or use-before date
• The net quantity or contents
• For sterile devices, the word "sterile" and the method of sterilisation
• Warnings, precautions and storage conditions, with instructions for use where needed

Where a device is made for another brand, the label must still show the actual manufacturing site and its license number. Regovex reviews labels and instructions for use against the rules and the Device Master File before printing.

How Regovex Handles Your Medical Device Manufacturing License in India

1. Free classification check of every device, including the non-sterile, non-measuring list
2. License route plan: state or CDSCO, own site or loan license, and a test license if needed
3. QMS gap analysis against the Fifth Schedule, and support to close the gaps
4. Device Master File and Plant Master File written or reviewed by our team
5. Application on ONDLS or your state drug licensing portal with fees and a complete document set
6. Notified body or CDSCO audit preparation, including a mock audit
7. Observation closure with clear evidence
8. After-care: retention fees, device additions, change approvals and vigilance support

Why Medical Device Manufacturers in India Choose Regovex

• Both routes under one roof. We handle state FDA approval for Class A and B and act as your CDSCO registration consultant for Class C, D, test licenses and imports.
• Technical files that hold together. Device Master File, Plant Master File, labels and test reports prepared as one consistent set.
• Experience with new categories. We research unlisted and borderline devices carefully before choosing a class.
• Support for medical device companies without a plant, through loan licenses and contract manufacturing reviews.
• Transparent pricing, with professional, government and notified body fees shown separately in writing.
• 99.8% approval rate across 100+ clients, rated 4.9/5 in verified client feedback.

Medical Device Manufacturing License Services in India and Nearby Areas

Regovex supports medical device manufacturers, IVD makers, start-ups, contract manufacturers and brand owners in India. Technical files are prepared with your team digitally, applications are filed on ONDLS or your state drug licensing portal, and we provide on-site support for QMS reviews and audits where needed.

We also serve manufacturers in .

Related services:

• Medical Device Registration in India
• Medical Device Import License (MD-14 / MD-15)
• CDSCO Registration in India
• Wholesale Drug License in India
• Drug Manufacturing License in India

What Our Clients Say

"I had great experience working with Regovex Consulting on the regulatory side of my product. Since the product category was relatively new and the guidelines were not very clearly defined, it required additional research and careful interpretation of the regulations." — Parichit Dhawan, Director, Feorah Wellness & Cosmetics

"I got my Drug Wholesale License through Regovex Consulting, and Devansh and his team provided complete end-to-end support, from premises selection to timely approval." — Bilal Ahmed Khan, Founder, Medwell Pharma

"Got my approval in committed time with complete transparency and zero hassle." — Baburam, Samarpaan Cloud Kitchen (FSSAI food license)

Other clients include Access 2 Healthcare for medical device import and Project Life for healthcare licensing.