Ministry of Health and Family Welfare
The Medical Devices Rules, 2017 document is structured to address regulatory needs across the lifecycle of
medical devices and in vitro diagnostics in India. Here’s an overview of the primary sections to help
identify areas relevant to your interest:
1. Definitions and Device Classification: Outlines medical device definitions and classifies devices
based on risk (Class A to D), from low to high. This is useful if you need to understand how your
device might be categorized and regulated.
Section 1. Definitions and Device Classification in the Medical Devices Rules, 2017 document
outlines key definitions and the basis for medical device classification. Here are the main points:
A. Definitions:
o Establishes terminology used across the document, such as "medical device,"
"notified body," and "predicate device," to clarify the regulatory scope.
o Defines various device-related terms (e.g., “quality management system,”
“performance evaluation”) to ensure consistent understanding.
B. Device Classification:
o Risk-Based Classes: Devices are classified into four categories based on risk:
Class A: Low risk (e.g., surgical dressings).
Class B: Low to moderate risk (e.g., hypodermic needles).
Class C: Moderate to high risk (e.g., lung ventilators).
Class D: High risk (e.g., heart valves).
o Basis for Classification: Classification depends on intended use, invasiveness,
duration of use, and the body's exposure to the device.
o Listing and Updates: The Central Licensing Authority periodically updates the list
of devices per class on the CDSCO website.
This section is fundamental for understanding which regulatory pathways apply based on device
risk.
2. Licensing Requirements: Details the forms and processes for licensing, including
manufacturing, import, and sale licenses. This section is crucial for manufacturers, importers, and
distributors seeking licenses for specific device classes.
Section 2. Licensing Requirements in the Medical Devices Rules, 2017 describes the application
and approval process for obtaining licenses for manufacturing, importing, and distributing
medical devices. Key highlights include:
a) License Application:
o Forms and Documentation: Applicants must submit specific forms (e.g., MD-3 for
manufacturing Class A and B devices and MD-7 for Class C and D devices), along with
documentation such as the site master file, quality policy, and device details.
o Online Portal: The Sugam online portal is designated for submitting license
applications.
b) Inspection and Verification:
o Site Inspection: Regulatory authorities conduct facility inspections to ensure
compliance with quality standards and safety requirements.
o Audit by Notified Bodies: Certain devices, especially Class C and D, require an audit
by notified bodies to verify conformity with standards before a license is granted.
c) License Duration and Renewal:
o Validity and Renewal: Licenses are valid for a specific period, typically five years,
and can be renewed by submitting required documents and fees before expiration.
d) Provisional Approval:
o Conditional Licenses: In certain cases, provisional licenses may be granted based
on a preliminary assessment, particularly for devices needed urgently for public
health.
e) Additional Endorsements:
o Adding New Devices: Existing license holders can apply to endorse additional
devices under the same license, provided these devices comply with the same
manufacturing standards.
This section is essential for manufacturers, importers, and distributors to understand the
regulatory requirements and processes for legally bringing medical devices to market.
3. Quality Management Systems (QMS): Specifies QMS requirements, particularly ISO 13485, for
safe and effective manufacturing practices. This is relevant if you're responsible for regulatory
compliance or quality assurance.
Section 3. Quality Management Systems (QMS) in the Medical Devices Rules, 2017 defines the
quality standards and management protocols that manufacturers must implement to ensure safe
and effective medical device production. Here are the highlights:
I. ISO 13485 Compliance:
o Manufacturers are required to follow ISO 13485 or equivalent QMS standards to
establish processes that meet regulatory requirements for medical devices.
o This includes maintaining documentation, standard operating procedures, and
controls to ensure consistent quality and safety.
II. Facility and Equipment Standards:
o Outlines criteria for the design, maintenance, and cleanliness of manufacturing
facilities and equipment to prevent contamination and ensure device safety.
o Emphasizes environmental control, such as air quality and sterility, particularly for
devices that require aseptic conditions.
III. Personnel Training and Qualification:
o Specifies requirements for qualified personnel with documented training and skills
relevant to device manufacturing.
o Ongoing training is emphasized to keep personnel updated on regulatory changes
and quality practices.
IV. Document Control and Traceability:
o Requires robust document control systems to track the history of each device batch
and trace any issues back to production records.
o This includes production batch records, material receipts, and quality control
documentation.
V. Risk Management and Continuous Improvement:
o Mandates a risk management plan to identify, assess, and mitigate risks throughout
the device lifecycle.
o Emphasizes continuous monitoring and improvement practices, including regular
audits and corrective actions when non-compliance is identified.
This section is critical for regulatory compliance officers, quality assurance teams, and
manufacturers, providing guidelines to ensure product quality and regulatory adherence.
4. Essential Safety and Performance Principles: Lists guidelines for safety and performance,
including materials, design, and usability standards. This section is key for product developers
and regulatory teams focusing on device safety.
Section 4. Essential Safety and Performance Principles in the Medical Devices Rules, 2017
provides guidelines to ensure that medical devices meet fundamental safety and performance
standards. Key highlights are as follows:
a. Device Design and Manufacturing:
o Devices must be designed and manufactured to be safe for use and perform as
intended under normal conditions.
o Design considerations should minimize risks related to device operation, such as
electrical, mechanical, or thermal hazards, and ensure that benefits outweigh any
residual risks.
b. Biocompatibility and Chemical Safety:
o Materials used in devices, especially those in contact with the human body, must be
biocompatible and free of harmful chemicals.
o Manufacturers must assess the chemical, physical, and biological compatibility of all
device materials to ensure patient safety.
c. Sterility and Cleanliness:
o For devices that require sterility, standards mandate sterilization processes to
ensure that no harmful microorganisms are present.
o Manufacturers are responsible for maintaining device sterility throughout the
manufacturing, packaging, and transportation processes.
d. Performance under Environmental Conditions:
o Devices should perform reliably under various environmental conditions they might
encounter during use.
o This includes ensuring the device is functional under specified temperature,
humidity, and pressure ranges, especially for devices used in critical settings like
hospitals.
e. Labeling and Instructions for Use:
o Clear labeling and instructions must be provided to ensure users understand the
device’s intended use, limitations, and operation.
o Labeling should include information on proper storage, handling, and any
precautions to reduce misuse and errors.
This section is essential for manufacturers and quality assurance teams to ensure compliance
with safety standards and mitigate risks associated with device use.
5. Clinical Investigation and Performance Evaluation: Includes requirements for clinical trials
and performance evaluations of devices, especially for in vitro diagnostics. It’s essential for
devices requiring evidence of safety and efficacy before market entry.
Section 5. Clinical Investigation and Performance Evaluation in the Medical Devices Rules,
2017 sets guidelines for conducting clinical studies to ensure the safety, efficacy, and performance
of medical devices, particularly for new or high-risk devices. Here are the main points:
A. Clinical Investigation Approval:
o Requires approval from the Central Licensing Authority before starting clinical
investigations, especially for devices that lack a similar predicate device.
o Applicants must submit clinical investigation protocols, informed consent
documents, and data on the device’s design and prior testing.
B. Ethics Committee Oversight:
o Clinical investigations must be approved by an Institutional Ethics Committee,
ensuring studies meet ethical standards and prioritize participant safety.
o Ongoing monitoring by the ethics committee is also required to ensure compliance
with approved protocols.
C. Study Design and Safety Monitoring:
o Investigations should follow scientifically sound protocols, including defined study
objectives, methods, and procedures to collect data on safety and performance.
o Emphasis is placed on risk management, requiring safety monitoring plans and the
reporting of adverse events to the regulatory authorities.
D. Informed Consent and Participant Rights:
o Manufacturers must ensure participants are informed about study risks, benefits,
and procedures through a clear, written consent form.
o Participants must be able to withdraw from the study at any time without facing any
penalties.
E. Data Reporting and Performance Evaluation:
o Study data must be documented, analyzed, and submitted to the regulatory body to
assess the device’s safety and efficacy.
o For in vitro diagnostic devices, performance evaluation includes assessing the
device's accuracy, precision, and sensitivity for its intended use.
This section is crucial for regulatory teams and clinical research organizations planning clinical
investigations for medical devices in India.
6. Post-Marketing Surveillance: Details the monitoring and reporting of adverse events after the
device is in the market. It applies if you are involved in post-market activities or product
monitoring.
Section 6. Post-Marketing Surveillance in the Medical Devices Rules, 2017 addresses the ongoing
monitoring of medical devices after they enter the market to ensure they remain safe, effective,
and compliant with regulatory standards. Key points include:
I. Continuous Monitoring:
o Manufacturers are required to conduct post-marketing surveillance (PMS) to track
the safety and performance of devices once they are sold to users.
o This includes gathering data on adverse events, device failures, or any incidents that
may affect the health of patients or users.
II. Reporting Adverse Events:
o The rules mandate that any adverse events, malfunctions, or risks identified after a
device’s release must be reported to the Central Drugs Standard Control
Organization (CDSCO) and the relevant state authorities.
o Manufacturers must have procedures for recalling, repairing, or replacing devices
that present safety concerns.
III. Post-Marketing Studies:
o Manufacturers may be required to conduct post-market clinical studies to further
evaluate a device’s long-term safety and effectiveness, particularly if new risks are
identified after market entry.
IV. Market Surveillance by Authorities:
o CDSCO and other regulatory bodies will conduct regular market surveillance,
including inspections and reviews of adverse event reports, to ensure manufacturers
comply with safety standards.
V. Corrective Actions:
o If post-marketing surveillance identifies issues, manufacturers must take corrective
actions, such as updating labeling, altering device specifications, or issuing safety
warnings to users.
This section is essential for device manufacturers and regulatory affairs professionals to ensure
that their products continue to meet safety standards throughout their lifecycle.
7. Standards for Import, Export, and Sale: Covers procedures for selling and distributing devices
across states and international borders. This is particularly useful for businesses involved in
trade.
Section 7. Standards for Import, Export, and Sale in the Medical Devices Rules, 2017 outlines
the regulatory requirements for the international trade and distribution of medical devices. Key
highlights include:
a. Import Licensing:
o Importers must obtain a license from the Central Licensing Authority (CLA) to
import medical devices into India.
o The license application must include detailed information about the device, its
manufacturer, and proof of compliance with Indian regulations (such as conformity
to safety and performance standards).
b. Export Requirements:
o Devices exported from India must meet the importing country's regulatory
requirements, including certifications and quality standards.
o Exporters must maintain records of the devices they export and provide information
to the CLA upon request, ensuring traceability.
c. Sale and Distribution:
o Devices intended for sale in India must be registered and licensed for sale or
distribution.
o Medical devices should only be sold by licensed distributors or retailers, and the
devices must be properly labeled with safety and usage instructions.
d. Compliance with International Standards:
o The rules encourage compliance with international standards, such as ISO
certifications, to facilitate the global trade of medical devices.
o Devices should meet the essential safety and performance requirements as outlined
in the document to ensure compliance with both domestic and international
regulations.
e. Penalties for Non-Compliance:
o Importers, manufacturers, and distributors who fail to comply with the licensing and
regulatory requirements may face penalties, including fines or suspension of
licenses.
o The CLA is authorized to take enforcement actions, including recalls or market bans,
for devices that do not meet safety or regulatory standards.
This section is important for businesses involved in the import, export, and sale of medical
devices, ensuring that devices meet both domestic and international regulatory standards.
Reference
Aspect Description
(Page Number)
Roles and responsibilities of the Central Licensing
Regulatory Authorities
Authority (CLA) and State Licensing Authorities for Page 1-3
and Enforcement
inspections and compliance enforcement.
Device Registration and Process for registering new devices, submitting technical
Page 4-6
Approval documentation, and approval for clinical trials.
Transitional Provisions Grace periods for devices already in the market before Page 7-8
and Exemptions the rule implementation and exemptions for certain
Reference
Aspect Description
(Page Number)
devices.
Details of fees for regulatory services such as licensing,
Fee Structure Page 8-9
registration, and approval processes.
Labeling and
Guidelines for labeling devices with essential information
Documentation Page 10-12
and providing instructions for use (IFU).
Requirements
Special Provisions for Specific provisions for in vitro diagnostic devices, covering
Page 13-15
IVDs approval and clinical evaluation processes.
Documentation and compliance requirements for
Importation and
importing and exporting devices, including quality Page 16-18
Exportation of Devices
certificates.
Penalties for non-compliance with the rules, including
Penalties and Offenses Page 19-20
fines and suspension of licenses.
e Description
Form MD-3: Application form for obtaining a license to manufacture or import
Annexure I
medical devices (Class A and B).
Form MD-7: Application form for higher risk devices (Class C and D), including
Annexure II
additional documentation for approval.
License Issuance Process: Details the procedures followed for issuing licenses,
Annexure III
including inspection and compliance checks.
List of Approved Standards: A reference list of international and national
Annexure IV
standards that devices must conform to.
Post-Marketing Surveillance Report Format: Template for manufacturers to
Annexure V
report post-marketing surveillance data, including adverse events.
Clinical Investigation Forms: Required templates for submitting clinical
Annexure VI
investigation protocols and data to regulatory authorities.
Fee Schedule: A detailed list of fees for licensing, registration, and other
Annexure VII
regulatory services under the rules.
List of Devices for Exemptions: A list of devices that may be exempt from certain
Annexure VIII
regulations, such as low-risk items.
Annexure IX Device Labeling Requirements: Guidelines and standards for labeling medical
e Description
devices, including required information for packaging and instructions for use.
