Understanding medical device classification in India is one of the first and most important steps for manufacturers and importers planning to market medical devices in the country.
Under the Medical Devices Rules, 2017 (MDR 2017), medical devices are classified according to their associated risk, intended purpose, technological characteristics, invasiveness, duration of use, and other applicable parameters. The classification of a device determines the regulatory pathway, applicable licensing authority, conformity assessment requirements, documentation, quality management obligations, and level of regulatory scrutiny.
MDR 2017 provides four statutory risk classes:
For practical purposes, Class A devices are often explained using three categories based on sterility and measuring function:
It is important to understand that these are six practical categories, not six separate statutory risk classes. Legally, MDR 2017 recognizes Classes A, B, C, and D.
What Is Medical Device Classification in India?
Medical device classification is the process of determining the risk category of a medical device based on its intended purpose and the classification rules prescribed under MDR 2017.
The classification is not determined simply by the product name. Manufacturers must evaluate factors such as:
The applicable rules in the First Schedule of MDR 2017 should be reviewed along with the current CDSCO classification list before finalizing the device classification.
Six Practical Categories of Medical Devices Under MDR 2017
1. Class A Non-Sterile and Non-Measuring Devices
Class A Non-Sterile and Non-Measuring medical devices generally represent the lowest-risk category.
These devices are:
Examples may include certain low-risk devices such as tongue depressors and examination couches, provided the intended purpose and applicable classification rule support Class A classification.
However, manufacturers should not classify a device solely on the basis of its product name. The intended purpose and applicable provisions of the First Schedule must always be considered.
Regulatory Considerations
For Class A non-sterile and non-measuring devices, manufacturers should pay particular attention to the applicable registration and regulatory provisions. The special Chapter IIIB registration provisions introduced through G.S.R. 777(E) are particularly relevant to this category.
Manufacturers should also verify the latest CDSCO requirements before commencing manufacturing or marketing activities.
2. Class A Sterile Medical Devices
Class A Sterile devices remain within the Class A risk category but are supplied in a sterile condition.
Sterility introduces additional compliance considerations because the manufacturer must ensure that the device remains sterile until its intended use.
Depending on the device, relevant considerations may include:
Is Class A Sterile a Separate Risk Class?
No.
This is an important distinction for manufacturers and importers.
Class A Sterile is not a separate statutory risk class under MDR 2017. It is a practical description of a Class A device based on its sterile status.
Therefore, the device remains Class A when the applicable classification rules place it in Class A.
3. Class A Measuring Medical Devices
A Class A Measuring device is a Class A medical device that performs a measuring function.
The measurement function may require manufacturers to consider additional technical and quality requirements relating to the accuracy and reliability of the measurement.
Depending on the device, manufacturers may need to address:
Does Having Markings Make a Device a Measuring Device?
Not necessarily.
A device should not automatically be classified as a Class A Measuring device simply because it contains numerical markings, graduations, scales, or other visual indicators.
The manufacturer should determine whether the device has an actual intended measuring function and whether the applicable classification provisions support the classification.
4. Class B Medical Devices – Low-Moderate Risk
Class B medical devices are considered low-moderate-risk devices under MDR 2017.
Compared with Class A devices, Class B devices generally require a higher level of regulatory control because their intended use, design, invasiveness, duration of use, or other characteristics may present a greater potential risk.
The First Schedule contains classification rules based on factors such as:
Certain short-term invasive devices may fall under Class B, while certain active devices may also be classified as Class B when the applicable classification rule is satisfied.
Class B Regulatory Requirements
Manufacturers of Class B devices must comply with the applicable MDR 2017 requirements, which may include:
The exact requirements depend on the device and the applicable regulatory pathway.
5. Class C Medical Devices – Moderate-High Risk
Class C medical devices fall into the moderate-high-risk category.
These devices require greater regulatory scrutiny because failure, malfunction, or incorrect performance may result in significant consequences for patients or users.
The First Schedule provides specific rules for determining whether a device falls into Class C.
Certain long-term invasive, implantable, or surgically invasive devices may be classified as Class C unless a specific rule places them in another class.
Certain active therapeutic devices that administer or exchange energy in a potentially hazardous manner may also fall into Class C under the applicable classification provisions.
Examples of Class C Devices
Depending on their intended purpose and applicable classification rule, examples may include certain:
These examples are illustrative only. A product should never be classified solely because it resembles an example.
Regulatory Control for Class C
Manufacture of Class C devices falls under the regulatory jurisdiction of the Central Licensing Authority.
Manufacturers may be required to meet requirements relating to:
6. Class D Medical Devices – High Risk
Class D medical devices represent the highest-risk category under MDR 2017.
These devices require the highest level of regulatory control because their failure, misuse, or incorrect performance may create serious risks to patients or users.
The First Schedule specifies circumstances in which devices may be classified as Class D.
For example, certain devices may fall into Class D when they are:
The applicable rules and exceptions must always be carefully reviewed.
Examples of Class D Devices
Depending on intended purpose and applicable classification rules, examples may include certain:
Again, these examples are illustrative. Final classification must be established using the applicable MDR 2017 classification rules and current CDSCO classification information.
Medical Device Classification in India: Quick Comparison
|
Category |
Risk Level |
Key Characteristics |
Regulatory Control |
|
Class A Non-Sterile & Non-Measuring |
Low |
Non-sterile and non-measuring |
Lower level of regulatory control |
|
Class A Sterile |
Low |
Class A device supplied sterile |
Additional sterility-related requirements |
|
Class A Measuring |
Low |
Class A device with measuring function |
Measurement-related requirements may apply |
|
Class B |
Low-Moderate |
Greater potential risk than Class A |
Increased regulatory requirements |
|
Class C |
Moderate-High |
Higher-risk devices |
Central regulatory oversight |
|
Class D |
High |
Highest-risk devices |
Highest level of regulatory scrutiny |
Important: The first three categories are practical descriptions within Class A. MDR 2017 legally establishes four risk classes: A, B, C, and D.
Why Is Correct Medical Device Classification Important?
Correct classification is the foundation of medical device regulatory compliance in India.
An incorrect classification can potentially result in:
For this reason, manufacturers and importers should establish the classification before beginning the licensing or registration process.
Frequently Asked Questions About Medical Device Classification in India
How many medical device risk classes are there under MDR 2017?
MDR 2017 provides four statutory risk classes: Class A, Class B, Class C, and Class D.
Class A is sometimes further explained as non-sterile/non-measuring, sterile, and measuring for practical purposes.
What is the lowest-risk medical device class in India?
Class A is the lowest-risk statutory category under MDR 2017.
What is the highest-risk medical device class in India?
Class D is the highest-risk category and is subject to the highest level of regulatory control.
Is Class A Sterile a separate statutory class?
No. Class A Sterile is not a separate statutory risk class. It is a Class A device supplied in a sterile condition.
Is Class A Measuring a separate statutory class?
No. Class A Measuring refers to a Class A device that has a measuring function. It is not a fifth statutory risk class.
Who regulates Class C and Class D medical device manufacturing?
Manufacture of Class C and Class D medical devices is regulated by the Central Licensing Authority.
Who regulates medical device imports in India?
The Central Licensing Authority is responsible for the import of medical devices of all classes.
Can a manufacturer classify a device based only on its product name?
No. Classification should be based on the device's intended purpose, characteristics, and applicable classification rules under MDR 2017.
Final Takeaway
Understanding medical device classification in India under MDR 2017 is essential for manufacturers, importers, and other stakeholders seeking to legally market medical devices in India.
The four statutory risk classes are:
Class A → Class B → Class C → Class D
with risk increasing from low to high.
For practical explanation, Class A devices may be discussed as:
However, these should not be confused with separate statutory risk classes.
The correct classification should always be determined by evaluating the intended purpose and applicable parameters under the First Schedule of MDR 2017, followed by verification against the current CDSCO classification information.
Once classification is established, manufacturers and importers can determine the appropriate licensing authority, conformity assessment pathway, quality management requirements, technical documentation, and other regulatory obligations.
Accurate classification is not simply a regulatory formality—it is the starting point for a compliant medical device approval and market-entry strategy in India.
Last Updated : 11 Aug 2026
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