CDSCO Medical Devices Rules-2017: Updated FAQs 2025

CDSCO Medical Devices Rules-2017: Updated FAQs 2025. The Indian medical device sector has witnessed significant transformation in recent years. The introduction of the Medical Devices Rules, 2017 (MDR-2017) marked a key milestone in ensuring the regulation and safety of medical devices within the country. These rules were designed to provide a robust regulatory framework to enhance the quality, safety, and efficacy of medical devices, creating a conducive environment for manufacturers, importers, and distributors. On April 3, 2025, the Central Drugs Standard Control Organization (CDSCO) published an addendum to its FAQs (Frequently Asked Questions) document, which clarifies various issues related to these regulations. This article examines the key elements of the Medical Device Rules, 2017, and discusses the recent updates and clarifications provided through the FAQs.
What is the Medical Device Rules 2017?
The Medical Devices Rules, 2017 (MD Rules, 2017), notified by the Central Drugs Standard Control Organization (CDSCO), came into effect on January 1, 2018. These rules were a long-awaited legislative framework to regulate the manufacture, import, sale, and distribution of medical devices in India. Prior to the introduction of these rules, medical devices were categorized and regulated under the Drugs and Cosmetics Act, 1940.
The new rules aimed to bring a separate regulatory framework for medical devices to ensure their safety, efficacy, and quality. The rules provide guidelines for classification, registration, licensing, and post-market surveillance of medical devices.
What Do the Medical Device Rules Cover?
The Medical Devices Rules, 2017 cover a wide range of activities concerning medical devices. Some of the key components of these rules include:
1. Classification of Medical Devices: The rules classify medical devices into four categories based on risk — Class A, Class B, Class C, and Class D. Each class has specific regulatory requirements, with Class A being the lowest risk and Class D being the highest.
2. Regulation of Manufacturing and Importing: The rules specify detailed procedures for the manufacturing, importing, and distribution of medical devices, including the requirements for a manufacturing license, quality management systems, and risk assessments.
3. Approval and Licensing: The rules require manufacturers and importers to obtain approval from CDSCO before launching their products in the Indian market. A License to CDSCO Manufacture and CDSCO Import License must be secured as part of the compliance process.
4. Clinical Investigations: Clinical trials or investigations are mandated for certain high-risk medical devices to demonstrate safety and efficacy before they can be marketed.
5. Registration and Post-Market Surveillance: Medical devices must be registered with CDSCO, and a strong post-market surveillance mechanism is in place to monitor the safety and performance of devices once they are available in the market.
6. Labelling and Packaging Requirements: The rules include strict guidelines on the labelling, packaging, and advertising of medical devices to ensure that they meet the required standards and provide clear, truthful information to users.
7. Regulation of Importers and Distributors: Importers and distributors of medical devices are required to obtain licenses from CDSCO, ensuring that imported devices meet the regulatory standards set by the authorities.
Recent Update: Addendum No. 01 to CDSCO FAQs
On April 3, 2025, CDSCO released an important update to its Frequently Asked Questions (FAQs) document regarding the Medical Devices Rules, 2017. The FAQ update provides much-needed clarity on various regulatory aspects of the rules, helping stakeholders in the medical device sector, including manufacturers, importers, and distributors, to better understand their obligations and compliance requirements.
The updated document, CDSCO/FAQ/MD/01 | Addendum No. 01, addresses common queries related to the registration, classification, and approval of medical devices in India, providing detailed guidance on compliance matters and regulatory processes. The FAQs cover topics ranging from the registration process to post-market surveillance and also address specific concerns regarding the implementation of new rules for emerging technologies and innovative devices.
Key FAQs from CDSCO Update 2025
Let us delve into the key FAQs from the CDSCO FAQ Addendum (April 2025) document, which provides critical updates and clarifications on the Medical Device Rules, 2017.
Biocompatibility Testing – Required for Devices in Contact with the Human Body (ISO 10993)
Q. Is biocompatibility testing required for medical devices that come into direct or indirect contact with the human body?
Answer: Yes, biocompatibility testing is mandatory for medical devices that come into contact with the human body. This is in accordance with ISO 10993, which is the international standard that defines the biological evaluation of medical devices. The scope of ISO 10993 extends to evaluating how a device interacts with tissues, cells, and biological systems.
Medical devices are classified into various categories based on the level and duration of contact with the human body (e.g., external devices, implantable devices, devices in contact with mucosal membranes, etc.). The specific biological risk assessments required will depend on the device's contact duration (e.g., short-term or long-term), and the intended use of the device. Devices like implantables or those in contact with the bloodstream must undergo rigorous testing to ensure cytotoxicity, sensitization, irritation, and other biological responses are minimized.
Manufacturers must submit biocompatibility test reports as part of the device registration and approval process with CDSCO. Failure to comply with these testing requirements could lead to regulatory delays or non-approval of the device for sale in India.
Sterilization & Parametric Release – Validation is Mandatory Before Initial Use
Q. Is validation of sterilization and parametric release mandatory for medical devices before they are used for the first time?
Answer: Yes, sterilization validation and parametric release are essential processes for medical devices that require sterilization before use, particularly for devices such as surgical instruments, implants, and other invasive medical devices.

Sterilization Validation: Manufacturers must ensure that the sterilization process used for the medical device is validated according to recognized international standards, such as ISO 11135 for ethylene oxide sterilization or ISO 17665 for steam sterilization. The sterilization process must be validated to demonstrate that it achieves the required sterility assurance level (SAL), ensuring that the device is free from harmful microorganisms.

Parametric Release: In some cases, parametric release may be used as an alternative to traditional sterility testing. Parametric release involves using process parameters (e.g., temperature, pressure, time, and humidity) to ensure that the sterilization process was successful, rather than relying solely on post-sterilization sterility testing. This process needs to be validated to demonstrate that it consistently produces devices that meet sterility requirements.

These validations must be completed before the initial use of the device, and the records must be submitted for regulatory review as part of the device registration process. If a device is found not to meet the validation standards, it may be rejected by regulatory authorities, resulting in delays and additional testing.
Expiry/Shelf Life Labeling – Non-Sterile Medical Devices Do Not Require an Expiry Date
Q. Do non-sterile medical devices require an expiry date?
Answer: Non-sterile medical devices do not require an expiry date unless the device is subject to degradation or other changes that could affect its performance or safety. The requirement for an expiry date or shelf life labeling is typically associated with sterile medical devices or devices that are subject to a specific shelf life due to their materials or intended use.
For example, sterile devices or devices with components that degrade over time (such as implants or drug-delivery devices) will require expiry dates to ensure that they are used within their validity period. However, for non-sterile devices, if the device is not expected to degrade or affect its functionality over time (e.g., external devices such as bandages or simple diagnostic tools), an expiry date is not necessary.
That said, it is crucial for manufacturers to evaluate their devices for any potential material degradation or performance issues over time and include a shelf-life date if needed, in accordance with regulatory guidelines. Any claim related to shelf life must be substantiated through appropriate testing and data.
Licensing & Registration Updates – Fresh Licenses Required for Company Constitution Changes
Q. Do changes in the company constitution (e.g., mergers, acquisitions, or changes in ownership) require fresh licensing and registration?
Answer: Yes, significant changes in the company constitution — such as mergers, acquisitions, changes in ownership, or changes to the legal entity under which the company operates — require a fresh license to be issued by CDSCO.
The registration process for medical devices is linked to the legal entity that holds the manufacturing or importing rights. If there are substantial changes to the company’s constitution, such as a change in ownership or a merger, the new entity will need to submit an application to CDSCO for a new manufacturing or import license. This ensures that the new entity meets all regulatory requirements and holds responsibility for the products it manufactures or distributes.
In addition, the registered name and address of the company will need to be updated in the official records maintained by CDSCO. Manufacturers and importers should notify the regulatory body of such changes in a timely manner to avoid non-compliance issues.
Import License & Manufacturing – Clarifications on Multiple Site Applications and Regulatory Approvals
Q. Can a manufacturer apply for an import license for multiple manufacturing sites, and what is the process for regulatory approvals?
Answer: Yes, a manufacturer can apply for an import license and regulatory approval for multiple manufacturing sites. However, each site must comply with the regulatory requirements set out by CDSCO and be subject to inspection to ensure that it adheres to Good Manufacturing Practices (GMP).
If a company operates multiple manufacturing sites, each site must provide details such as:

The address of the manufacturing unit.

The devices being manufactured at each site.

The processes in place for quality control and testing.

The regulatory authority will then assess each site separately and approve the application for an import license if the site meets the required standards. This ensures that the entire supply chain for the medical device, whether domestically produced or imported, is compliant with Indian regulations.
It is important for manufacturers to submit a separate application for each site, clearly stating the details of the devices produced and their compliance with Indian safety and quality standards.
ISO 13485 Compliance – Is It Mandatory for Manufacturers in India?
Q. Is compliance with ISO 13485 mandatory for medical device manufacturers in India?
Answer: While ISO 13485 is not legally mandatory under the Medical Device Rules, 2017, it is strongly recommended and is a widely recognized international standard for quality management systems (QMS) in the medical device industry. Compliance with ISO 13485 ensures that manufacturers follow best practices for producing high-quality and safe medical devices.
The ISO 13485 standard helps manufacturers maintain effective quality management systems, which cover key aspects such as:

Design and development processes.

Manufacturing controls.

Supplier and vendor management.

Document control and traceability.

Although ISO 13485 is not an explicit regulatory requirement under the Medical Device Rules, CDSCO may prefer or expect manufacturers to demonstrate ISO 13485 certification as part of their application for device approval, particularly for higher-risk devices. Manufacturers are also encouraged to obtain this certification as it aids in compliance with international regulatory requirements, such as those from the U.S. FDA and the European Union (EU).
Conclusion
The Medical Devices Rules, 2017 were introduced to regulate the medical device sector in India and ensure the safety, quality, and effectiveness of medical devices. The recent update from CDSCO, in the form of the FAQ Addendum dated April 3, 2025, provides much-needed clarity on the implementation and compliance aspects of these rules. These FAQs clarify several critical issues related to device classification, registration, manufacturing licenses, clinical trials, and post-market surveillance, thereby helping manufacturers and stakeholders navigate the regulatory landscape with greater ease.
It is important for all stakeholders involved in the medical device industry to stay informed about these updates to ensure compliance with the Medical Devices Rules, 2017 and contribute to the development of a safer and more reliable healthcare ecosystem in India.

The Indian medical device sector has witnessed significant transformation in recent years. The introduction of the Medical Devices Rules, 2017 (MDR-2017) marked a key milestone in ensuring the regulation and safety of medical devices within the country. These rules were designed to provide a robust regulatory framework to enhance the quality, safety, and efficacy of medical devices, creating a conducive environment for manufacturers, importers, and distributors. On April 3, 2025, the Central Drugs Standard Control Organization (CDSCO) published an addendum to its FAQs (Frequently Asked Questions) document, which clarifies various issues related to these regulations. This article examines the key elements of the Medical Device Rules, 2017, and discusses the recent updates and clarifications provided through the FAQs.

What is the Medical Device Rules 2017?

The Medical Devices Rules, 2017 (MD Rules, 2017), notified by the Central Drugs Standard Control Organization (CDSCO), came into effect on January 1, 2018. These rules were a long-awaited legislative framework to regulate the manufacture, import, sale, and distribution of medical devices in India. Prior to the introduction of these rules, medical devices were categorized and regulated under the Drugs and Cosmetics Act, 1940.

The new rules aimed to bring a separate regulatory framework for medical devices to ensure their safety, efficacy, and quality. The rules provide guidelines for classification, registration, licensing, and post-market surveillance of medical devices.

What Do the Medical Device Rules Cover?

The Medical Devices Rules, 2017 cover a wide range of activities concerning medical devices. Some of the key components of these rules include:

1. Classification of Medical Devices: The rules classify medical devices into four categories based on risk — Class A, Class B, Class C, and Class D. Each class has specific regulatory requirements, with Class A being the lowest risk and Class D being the highest.

2. Regulation of Manufacturing and Importing: The rules specify detailed procedures for the manufacturing, importing, and distribution of medical devices, including the requirements for a manufacturing license, quality management systems, and risk assessments.

3. Approval and Licensing: The rules require manufacturers and importers to obtain approval from CDSCO before launching their products in the Indian market. A License to CDSCO Manufacture and CDSCO Import License must be secured as part of the compliance process.

4. Clinical Investigations: Clinical trials or investigations are mandated for certain high-risk medical devices to demonstrate safety and efficacy before they can be marketed.

5. Registration and Post-Market Surveillance: Medical devices must be registered with CDSCO, and a strong post-market surveillance mechanism is in place to monitor the safety and performance of devices once they are available in the market.

6. Labelling and Packaging Requirements: The rules include strict guidelines on the labelling, packaging, and advertising of medical devices to ensure that they meet the required standards and provide clear, truthful information to users.

7. Regulation of Importers and Distributors: Importers and distributors of medical devices are required to obtain licenses from CDSCO, ensuring that imported devices meet the regulatory standards set by the authorities.

Recent Update: Addendum No. 01 to CDSCO FAQs

On April 3, 2025, CDSCO released an important update to its Frequently Asked Questions (FAQs) document regarding the Medical Devices Rules, 2017. The FAQ update provides much-needed clarity on various regulatory aspects of the rules, helping stakeholders in the medical device sector, including manufacturers, importers, and distributors, to better understand their obligations and compliance requirements.

The updated document, CDSCO/FAQ/MD/01 | Addendum No. 01, addresses common queries related to the registration, classification, and approval of medical devices in India, providing detailed guidance on compliance matters and regulatory processes. The FAQs cover topics ranging from the registration process to post-market surveillance and also address specific concerns regarding the implementation of new rules for emerging technologies and innovative devices.

Key FAQs from CDSCO Update 2025

Let us delve into the key FAQs from the CDSCO FAQ Addendum (April 2025) document, which provides critical updates and clarifications on the Medical Device Rules, 2017.

Biocompatibility Testing – Required for Devices in Contact with the Human Body (ISO 10993)

Q. Is biocompatibility testing required for medical devices that come into direct or indirect contact with the human body?

Answer: Yes, biocompatibility testing is mandatory for medical devices that come into contact with the human body. This is in accordance with ISO 10993, which is the international standard that defines the biological evaluation of medical devices. The scope of ISO 10993 extends to evaluating how a device interacts with tissues, cells, and biological systems.

Medical devices are classified into various categories based on the level and duration of contact with the human body (e.g., external devices, implantable devices, devices in contact with mucosal membranes, etc.). The specific biological risk assessments required will depend on the device's contact duration (e.g., short-term or long-term), and the intended use of the device. Devices like implantables or those in contact with the bloodstream must undergo rigorous testing to ensure cytotoxicity, sensitization, irritation, and other biological responses are minimized.

Manufacturers must submit biocompatibility test reports as part of the device registration and approval process with CDSCO. Failure to comply with these testing requirements could lead to regulatory delays or non-approval of the device for sale in India.

Sterilization & Parametric Release – Validation is Mandatory Before Initial Use

Q. Is validation of sterilization and parametric release mandatory for medical devices before they are used for the first time?

Answer: Yes, sterilization validation and parametric release are essential processes for medical devices that require sterilization before use, particularly for devices such as surgical instruments, implants, and other invasive medical devices.

Sterilization Validation: Manufacturers must ensure that the sterilization process used for the medical device is validated according to recognized international standards, such as ISO 11135 for ethylene oxide sterilization or ISO 17665 for steam sterilization. The sterilization process must be validated to demonstrate that it achieves the required sterility assurance level (SAL), ensuring that the device is free from harmful microorganisms.
Parametric Release: In some cases, parametric release may be used as an alternative to traditional sterility testing. Parametric release involves using process parameters (e.g., temperature, pressure, time, and humidity) to ensure that the sterilization process was successful, rather than relying solely on post-sterilization sterility testing. This process needs to be validated to demonstrate that it consistently produces devices that meet sterility requirements.

Expiry/Shelf Life Labeling – Non-Sterile Medical Devices Do Not Require an Expiry Date

Q. Do non-sterile medical devices require an expiry date?

Answer: Non-sterile medical devices do not require an expiry date unless the device is subject to degradation or other changes that could affect its performance or safety. The requirement for an expiry date or shelf life labeling is typically associated with sterile medical devices or devices that are subject to a specific shelf life due to their materials or intended use.

For example, sterile devices or devices with components that degrade over time (such as implants or drug-delivery devices) will require expiry dates to ensure that they are used within their validity period. However, for non-sterile devices, if the device is not expected to degrade or affect its functionality over time (e.g., external devices such as bandages or simple diagnostic tools), an expiry date is not necessary.

That said, it is crucial for manufacturers to evaluate their devices for any potential material degradation or performance issues over time and include a shelf-life date if needed, in accordance with regulatory guidelines. Any claim related to shelf life must be substantiated through appropriate testing and data.

Licensing & Registration Updates – Fresh Licenses Required for Company Constitution Changes

Q. Do changes in the company constitution (e.g., mergers, acquisitions, or changes in ownership) require fresh licensing and registration?

Answer: Yes, significant changes in the company constitution — such as mergers, acquisitions, changes in ownership, or changes to the legal entity under which the company operates — require a fresh license to be issued by CDSCO.

The registration process for medical devices is linked to the legal entity that holds the manufacturing or importing rights. If there are substantial changes to the company’s constitution, such as a change in ownership or a merger, the new entity will need to submit an application to CDSCO for a new manufacturing or import license. This ensures that the new entity meets all regulatory requirements and holds responsibility for the products it manufactures or distributes.

In addition, the registered name and address of the company will need to be updated in the official records maintained by CDSCO. Manufacturers and importers should notify the regulatory body of such changes in a timely manner to avoid non-compliance issues.

Import License & Manufacturing – Clarifications on Multiple Site Applications and Regulatory Approvals

Q. Can a manufacturer apply for an import license for multiple manufacturing sites, and what is the process for regulatory approvals?

Answer: Yes, a manufacturer can apply for an import license and regulatory approval for multiple manufacturing sites. However, each site must comply with the regulatory requirements set out by CDSCO and be subject to inspection to ensure that it adheres to Good Manufacturing Practices (GMP).

If a company operates multiple manufacturing sites, each site must provide details such as:

The address of the manufacturing unit.
The devices being manufactured at each site.
The processes in place for quality control and testing.

It is important for manufacturers to submit a separate application for each site, clearly stating the details of the devices produced and their compliance with Indian safety and quality standards.

ISO 13485 Compliance – Is It Mandatory for Manufacturers in India?

Q. Is compliance with ISO 13485 mandatory for medical device manufacturers in India?

Answer: While ISO 13485 is not legally mandatory under the Medical Device Rules, 2017, it is strongly recommended and is a widely recognized international standard for quality management systems (QMS) in the medical device industry. Compliance with ISO 13485 ensures that manufacturers follow best practices for producing high-quality and safe medical devices.

The ISO 13485 standard helps manufacturers maintain effective quality management systems, which cover key aspects such as:

Design and development processes.
Manufacturing controls.
Supplier and vendor management.
Document control and traceability.

Conclusion

The Medical Devices Rules, 2017 were introduced to regulate the medical device sector in India and ensure the safety, quality, and effectiveness of medical devices. The recent update from CDSCO, in the form of the FAQ Addendum dated April 3, 2025, provides much-needed clarity on the implementation and compliance aspects of these rules. These FAQs clarify several critical issues related to device classification, registration, manufacturing licenses, clinical trials, and post-market surveillance, thereby helping manufacturers and stakeholders navigate the regulatory landscape with greater ease.

It is important for all stakeholders involved in the medical device industry to stay informed about these updates to ensure compliance with the Medical Devices Rules, 2017 and contribute to the development of a safer and more reliable healthcare ecosystem in India.