Class A Medical Device Registration in India: Non-Sterile, Non-Measuring Devices, CDSCO Process and List

What Is Class A Medical Device Registration?

Class A medical device registration is the simplified approval route CDSCO provides for the lowest-risk medical devices. Under the Medical Devices Rules, 2017, every regulated device falls into Class A, B, C or D. Class A devices that are both non-sterile and non-measuring, and that appear on CDSCO's published list, are exempted from the manufacturing and import licence requirements. Instead, the manufacturer or importer obtains a registration number from ONDLS or your state drug licensing portal by submitting the device and site details with self-declarations.

This is what people usually mean when they search for class a non sterile medical device registration india or low risk medical device registration india. It is the fastest legal route to market for products such as non-sterile bandages, walking aids and simple examination tools, but it only applies when every condition is met. A CDSCO class A medical device that is sterile, has a measuring function, or is not on the list still needs a full licence.

What is a class A non sterile non measuring medical device?

A class A non sterile non measuring medical device is one that meets three tests at the same time:

1. It is Class A, the lowest-risk class under the First Schedule of the Medical Devices Rules, 2017.
2. It is non-sterile: it is not supplied sterile and is not meant to be sterilised before use as part of its labelled claim.
3. It is non-measuring: it does not have a measuring function, such as a scale, a graduated volume or a reading the user relies on.

In addition, the device should appear on CDSCO's list of Class A non-sterile, non-measuring devices, which CDSCO updates from time to time.

Sterile or non-sterile, measuring or non-measuring: how to tell

The two words that decide the exemption are easy to misread. A device is sterile if it is supplied sterile, labelled sterile, or sold in a sterile barrier pack, even when the user could also use it non-sterile. A device that the user is expected to sterilise before use, such as a reusable surgical instrument, is supplied non-sterile, and that is how CDSCO's list describes such items. A device has a measuring function when it gives the user a value they rely on: a scale, a graduated volume, a reading in units or a calibrated mark.

If your product range includes both versions of the same item, such as sterile and non-sterile dressings, the non-sterile line can be registered and the sterile line licensed. Make sure the packs are clearly different, so the wrong product never goes out under the registration number.

Is License Required for Class A Medical Device?

The short answer to is license required for class a medical device is: it depends on which kind of Class A device you have.

So the non sterile non measuring medical device exempt license rule is a targeted exemption, not a blanket one. The exemption covers the licence only: the device still has to be registered, labelled correctly, made to the applicable standards and monitored after sale. Selling or distributing the device also needs a sale registration (MD-42) or a drug sale licence from the State Drug Licensing Authority, unless the seller is the registered manufacturer or importer selling its own products.

Why the exemption matters

A Class A manufacturing licence needs a quality management system, an audit by a notified body after grant and per-device fees; an import licence needs a Device Master File, a Plant Master File and fees in US dollars. For a simple non-sterile product, registration avoids all of that, which is why confirming eligibility first can save months and a significant amount of money.

Who Needs Class A Medical Device Registration?

Class A medical device registration is used by:

• Indian manufacturers of non-sterile, non-measuring low-risk products such as bandages, cotton, supports, binders and mobility aids
• Importers and authorised agents bringing listed Class A devices into India from abroad
• Contract manufacturers and brand owners selling Class A products under their own brand, where the brand owner is the legal manufacturer
• Hospital and home-care suppliers who make or import simple consumables and aids
• D2C and e-commerce health brands selling low-risk devices online, where marketplaces ask for a CDSCO number

If you only buy and resell devices made or imported by someone else, you do not register the device yourself. You rely on the maker's or importer's registration or licence, and you need a sale registration (MD-42) or a drug sale licence for your own premises. Ask your supplier for the registration or licence number and check it appears on the label before you stock the product.

Medical Device Classification India: Class A, B, C and D

Medical device classification India follows the First Schedule of the Medical Devices Rules, 2017, which sorts every device by risk. The medical device classification class A B C D system looks at what the device is meant to do, how long it stays in contact with the body, whether it is invasive, whether it is active (powered) and whether it is implanted.

The rules define duration of use in three bands: transient (normally less than 60 minutes of continuous use), short-term (60 minutes to 30 days) and long-term (more than 30 days). A device that is used on intact skin for a short time is usually Class A; the same type of device that enters the body or stays in place longer moves up a class. IVDs are classified on a separate A to D scale based on the risk to the patient and to public health.

In practice, medical device classification India is decided by intended use more than by the product's appearance. The same strip of fabric can be an ordinary garment, a Class A support when sold to hold a limb in place, or a higher-class product when it carries a drug or is meant for wound contact on broken skin. Write the intended use first, in the words you will use on the label and in marketing, and then classify. If two classes seem possible, the higher one applies until CDSCO confirms otherwise. This step also decides whether you can use the registration route, or need a class A medical device manufacturing license or an import licence, so it is worth getting a second opinion before you print packs.

CDSCO publishes product-wise risk classification lists for each specialty, such as general hospital, orthopaedics, dental, ENT and rehabilitation. Always check your device against the current list before choosing a route, because the list, not the general rules alone, is what CDSCO applies first.

Class A IVDs follow their own classification

In-vitro diagnostic devices are classified on a separate scale, and Class A IVDs are general laboratory products and low-risk reagents rather than the physical products on the device list. Do not assume an IVD is covered by the non-sterile, non-measuring exemption just because it is Class A; check whether CDSCO's list actually covers that IVD before choosing a route. Most IVDs, including Class A ones, are licensed through MD-5 for manufacture or MD-15 for import.

Class A Medical Devices Examples

The class A medical devices examples below are typical of products that are Class A under CDSCO's lists when supplied non-sterile and without a measuring function. Always confirm each product against the current list, since a sterile or measuring version of the same product is treated differently.

Tongue depressor medical device classification

The tongue depressor medical device classification is a good example of how the rules work. A plain wooden or plastic tongue depressor touches only the mouth briefly, has no measuring function and carries very low risk, so it is generally Class A. If it is supplied non-sterile and appears on CDSCO's non-sterile, non-measuring list, it can be registered instead of licensed. A tongue depressor supplied sterile, in individual sterile packs, is still Class A but no longer qualifies for the exemption, and needs a manufacturing or import licence.

Class A Medical Device List India: Where to Check

The class A medical device list India manufacturers and importers rely on is CDSCO's list of Class A non-sterile, non-measuring medical devices, published under the Medical Devices Rules, 2017 and revised from time to time. It sits alongside CDSCO's broader risk classification lists, which show the class of thousands of devices across specialties.

To use the list of non sterile class a medical devices correctly:

1. Find your device by generic name and intended use, not by brand name. The list describes devices by what they do.
2. Check the description matches your product exactly, including whether it is reusable or single-use and what it is used for.
3. Confirm your product is supplied non-sterile and has no measuring function. Labels and instructions that claim sterility or show a measuring scale take the product out of the exemption.
4. Check the latest version. CDSCO updates the list, so a device that was not on an older version may now be listed, and vice versa.
5. If your device is not listed, do not assume it is exempt. Either it needs a licence, or CDSCO's classification must be sought before you sell.

Regovex checks every product in your range against the current list and the risk classification lists, and gives you a written classification note for each, so you know exactly which items can be registered and which need a licence.

Class A Medical Device Registration Process: Step by Step

The class A medical device registration process for a non-sterile, non-measuring device is short, but each step needs care because the registration rests on your own declarations.

1. Classify the device. Confirm it is Class A under CDSCO's risk classification lists, then check it against the non-sterile, non-measuring list.
2. Check the label claims. Make sure the label, instructions and marketing do not claim sterility or show a measuring function.
3. Register the applicant. The manufacturer, or for imported devices the importer or authorised agent, creates an account on ONDLS or your state drug licensing portal with identity and address proof.
4. Enter device details: generic name, intended use, model or catalogue numbers, and the manufacturing site.
5. Upload the declarations: an undertaking that the device is Class A, non-sterile and non-measuring; a self-certification against the essential principles of safety and performance; and a self-certification of compliance with the applicable standards.
6. Submit and receive the registration number. The number is issued through the online system once the submission is accepted.
7. Print the number on the label and keep the registration record with your device files.

Documents for Class A registration

• Applicant's company documents, identity and address proof
• Manufacturing site address and details, with the site's licence or registration where it is abroad
• Device list with generic names, intended use and models
• Undertaking that each device is Class A, non-sterile and non-measuring
• Self-certification of conformity with the essential principles checklist
• Self-certification of compliance with the applicable standards (Indian standards first, then international ones such as ISO standards)
• Labels and instructions for use
• For importers: the overseas manufacturer's details and its authorisation for the Indian applicant

Class A Medical Device Registration Fee

The class A medical device registration fee depends on the route:

For most small manufacturers, the bigger cost is not the government fee but the professional time spent classifying products and preparing labels and declarations correctly. A wrong declaration that a sterile or measuring product is exempt can lead to the registration being cancelled and stock being withdrawn.

Registration vs licence: a typical timeline

The difference in time is the main commercial reason to confirm eligibility for registration before preparing a licence file.

Class A Medical Device Import

A class A medical device import follows the same split. If the device is on CDSCO's non-sterile, non-measuring list, the Indian importer or authorised agent registers it on the online system with the overseas manufacturer's details and the declarations, and can then import it without an MD-15 licence. If the device is sterile, has a measuring function or is not on the list, the importer needs a full MD-15 import licence, applied for on MD-14 with a Device Master File, Plant Master File, free sale certificate and ISO 13485 certificate. CDSCO can take up to nine months to decide an MD-14.

Importers should also remember that the warehouse they sell from needs a state sale registration (MD-42) or a drug sale licence, and that every imported device must carry the importer's details and the registration or licence number on the label. Our Medical Device Import License page covers the MD-14 route in full.

Class A Medical Device Manufacturing License: When You Still Need One

If your Class A device is sterile or measuring, or not on the list, you need a class A medical device manufacturing license on Form MD-5, applied for on Form MD-3 to the State Licensing Authority, which in India is the State Drug Licensing Authority. For Class A, the licence is granted on the basis of the application and documents, without a prior audit, within 45 days. A notified body then audits the site within 120 days of grant to verify the quality management system. The fee is ₹5,000 per site and ₹500 per distinct device, and the licence is valid in perpetuity with a retention fee every five years.

A Class A manufacturing licence needs a quality management system meeting the Fifth Schedule of the rules, competent technical staff, suitable premises and device files. Manufacturers that make a mix of exempt and non-exempt Class A products can register the exempt items and license the rest; Regovex plans both together. See our Medical Device Manufacturing License page for the full process.

Non Notified Medical Device Registration: How the Rules Changed

Many search results still talk about non notified medical device registration, and it helps to know where the term comes from. Until 2020, only a limited set of devices had been notified as drugs and needed licences. Everything else, the non notified medical devices CDSCO did not yet license, could be sold without approval.

The registration numbers issued for non-notified devices during the 2020 to 2022 phase were transitional and did not replace the licences that became mandatory later. If your company still relies on an old registration number for a device that now needs a licence, it should be licensed, or confirmed as exempt, without delay.

Voluntary registration class A medical device CDSCO: is it still voluntary?

No. The phrase voluntary registration class A medical device CDSCO comes from the first 18 months of the 2020 scheme, when registration of non-notified devices was optional. Today, registration is the condition for using the Class A exemption: a manufacturer or importer that wants to sell a listed non-sterile, non-measuring device without a licence must hold the registration number. A device sold with neither a licence nor a registration is being sold in breach of the rules.

If your device already has a licence

Some manufacturers obtained an MD-5 licence for Class A products before CDSCO's non-sterile, non-measuring list was settled, and later find their device on the list. A valid licence remains valid, and many companies simply keep it, especially when the same site also makes licensed products. Moving a product from a licence to registration is a decision to plan carefully: check that the product, its label and its claims fully meet the exemption, and keep your quality system in place, since it supports the self-certifications you will make. Regovex can review your licensed range and tell you which items could move to registration and whether it is worth doing.

After Registration: Staying Compliant

The exemption removes the licence, not the responsibility. After registration:

• Labels must show the registration number and the other particulars required by the Medical Devices Rules, 2017, including the manufacturer's or importer's name and address, batch or lot number and date of manufacture
• Standards declared in the self-certification must actually be met, with test records to prove it
• Records of manufacture or import and of sale should be kept so that any batch can be traced
• Complaints and adverse events must be recorded, investigated and reported to CDSCO as the rules require, and recalls carried out when needed
• Changes in the device, its intended use, the site or the company details must be updated on the online system
• New products must be checked against the list and registered before sale; one registration does not cover future products automatically
• Sale licences for warehouses and distributors still apply

A product that is found to be sterile, measuring or not on the list after registration can have its registration cancelled, and the manufacturer can be asked to withdraw stock. Getting the classification right at the start is far cheaper than fixing it later.

Labelling a registered Class A device

The label is where inspectors, hospital buyers and marketplaces check your registration. For a registered Class A device, the label should carry the device's name and intended use, the name and address of the manufacturer (and of the importer for imported devices), the CDSCO registration number, the batch or lot number, the date of manufacture and, where relevant, a use-before date and storage instructions. Keep the label free of words such as sterile, and of scales, graduations or readings that could be taken as a measuring function. When you print the registration number, use it only on the products and models entered against it on the online system; using one number across an unregistered product line is a common and serious error.

Class A Devices for Marketplace and D2C Sellers

Online marketplaces now ask sellers of medical devices to show a CDSCO registration or licence number for each listing, and many delist products without one. For a D2C brand selling supports, braces, mobility aids or non-sterile consumables, Class A registration is often the quickest way to meet that requirement. Two cautions apply. First, product descriptions online count as claims: a listing that calls a non-sterile dressing sterile, or adds a measuring feature, can take the product outside the exemption. Second, the seller's warehouse or fulfilment centre still needs a sale licence or MD-42 registration. Regovex reviews listings as well as packs, so what you say online matches what you registered.

Common Mistakes in Class A Registration

• Assuming every Class A device is exempt, including sterile or measuring ones
• Registering a device that is not on CDSCO's non-sterile, non-measuring list
• Labels or marketing that claim sterility, or packs printed with measuring marks
• Relying on an old non-notified registration number from 2020 to 2022
• Registering one model and selling others not entered on the system
• Forgetting that the distributor's warehouse still needs a sale licence or MD-42
• Self-certifying standards without test records to support the declaration

Checklist Before You Register a Class A Device

• Device confirmed as Class A under CDSCO's risk classification lists
• Device found on the current Class A non-sterile, non-measuring list
• Labels, instructions and online listings free of sterility or measuring claims
• Generic name, intended use and models defined for each product
• Manufacturing site details ready, with the overseas site's documents for imports
• Applicable standards identified and test records available
• Self-certifications and undertaking drafted and signed
• Applicant account active on the online system
• Sale licence or MD-42 arranged for the warehouse
• Plan for complaints, adverse events and recalls in place

Working through this list keeps your class A medical device registration process quick and your registration safe from later cancellation.

How Regovex Handles Your Class A Medical Device Registration in India

1. Free classification check. We review each product's intended use, sterility and any measuring function, and check it against CDSCO's risk classification lists and the non-sterile, non-measuring list.
2. Written classification note for every product, showing whether it can be registered or needs an MD-5 or MD-15 licence.
3. Label and claims review, so nothing on the pack takes the product out of the exemption.
4. Account set-up and filing on ONDLS or your state drug licensing portal, with device details and declarations.
5. Standards and records guidance, so your self-certification is backed by test records.
6. Licence filings for any products that are not exempt, and MD-42 or sale licence support for your warehouse.
7. Ongoing support for new products, changes and complaint handling.

Why Manufacturers and Importers Choose Regovex as Their CDSCO Registration Consultant

• Classification first. We start with the question that decides cost and time: is your device really exempt?
• Every device route under one roof, from Class A registration to MD-5, MD-9, MD-15 and MD-42, as a CDSCO registration consultant and drug regulatory consultant in India.
• Practical label and standards advice that keeps the exemption safe after registration.
• Clear pricing, with government and professional fees shown separately in writing.
• 99.8% approval rate across 100+ clients, rated 4.9/5 in verified client feedback.
• One point of contact for your whole product range.

Class A Medical Device Registration Services in India and Nearby Areas

Regovex handles Class A registrations and licences for manufacturers, importers, hospital suppliers and D2C health brands in India. Documents are collected digitally, and filings are made on ONDLS or your state drug licensing portal. Our office is in Aligarh, and we work with clients across Delhi NCR, Uttar Pradesh and the rest of India.

We also serve device businesses in .

Related services:

• CDSCO Registration in India
• Medical Device Manufacturing License (Class A–D)
• Medical Device Import License (MD-14 / MD-15)
• MD-42 Wholesale Registration
• Medical Device Test License

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

Medical device clients include Access 2 Healthcare.