MEDICAL DEVICES | REGISTRATION AND LICENSING
Medical Device Registration in India
Regulatory Documentation and Licensing Assistance for Medical Device Businesses
Planning to manufacture, import, sell or distribute medical devices
in India? BBSR Services assists businesses with preliminary
regulatory requirement assessment, document preparation and
application coordination based on the device category, risk class,
intended use and proposed business activity.
What Is Medical Device Registration?
Medical device registration and licensing refer to the regulatory
requirements that may apply to medical devices and the businesses
responsible for manufacturing, importing, selling or distributing them.
In India, medical devices are regulated under the Drugs and Cosmetics
Act, 1940 and the Medical Devices Rules, 2017, together with applicable
amendments, notifications and directions.
A medical device may include an instrument, apparatus, appliance,
implant, material, software or accessory intended for a specified
medical purpose. The regulatory treatment depends on the manufacturer's
intended use, device characteristics, applicable definitions and
risk classification.
Medical devices are generally classified into four risk categories:
Class A (low risk), Class B (low to moderate risk), Class C
(moderate to high risk) and Class D (high risk). The classification
should be verified against the applicable rules and official
classification guidance.
Not every application follows the same route. Importing, manufacturing,
sale and distribution can involve different application requirements
and licensing authorities. Some specifically exempted device categories
may be treated differently under applicable notifications.
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Identify the Correct Regulatory Route Before Applying
Device name alone may not be enough to determine the applicable
requirements. The intended use, product specifications, risk
classification, manufacturing location, applicant role and
existing approvals should be reviewed before preparing an
application.
Our Medical Device Registration Assistance
BBSR Services can help businesses organise documentation and coordinate
registration or licensing applications within the agreed scope.
Regulatory eligibility, technical requirements and the appropriate
authority must be confirmed for the particular device and activity.
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Regulatory Requirement Assessment
Review the proposed device, intended use, applicant details
and business activity to identify the regulatory questions
that need to be confirmed.
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Device Risk Classification Support
Help organise product information for classification assessment
against the applicable rules and official device-specific
classification guidance.
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Manufacturing Licence Documentation
Assist with compiling applicant, manufacturing site and
supporting documents for the relevant manufacturing
application route.
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Medical Device Import Licensing
Help organise importer and product documentation for the
applicable import licence application and associated
regulatory submissions.
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Technical Dossier Coordination
Coordinate the collection of available product descriptions,
specifications, labelling, risk-related records and other
applicable technical documents.
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Application and Renewal Support
Assist with application paperwork, supporting documents,
clarification responses and applicable amendment or renewal
processes within the agreed scope.
Types of Medical Devices
Medical devices cover a wide range of products. The following examples
are illustrative only; they do not assign a risk class or confirm
regulatory eligibility for a specific product.
Medical Device Risk Classification in India
The applicable class should be established using the Medical Devices
Rules, relevant schedules and official classification guidance.
The summary below describes the broad risk categories only.
Class A - Low Risk
Devices generally associated with the lowest risk category.
Specific requirements and any applicable exemption must be
checked for the individual device.
Class B - Low to Moderate Risk
Devices assigned to the low-to-moderate risk category.
Applicable licensing and technical documentation requirements
depend on the product and activity.
Class C - Moderate to High Risk
Devices assigned to the moderate-to-high risk category.
The applicable manufacturing route involves the Central
Licensing Authority under the current framework.
Class D - High Risk
Devices assigned to the highest risk category. Their
regulatory assessment and licensing requirements must be
determined using the applicable rules and product details.
Which Medical Device Licence May Apply?
The application route depends on whether the applicant is manufacturing
for sale or distribution, importing devices, or undertaking sale and
distribution activities. The authority and forms must be confirmed
under the current Medical Devices Rules and applicable notifications.
Manufacturing - Class A and B
Manufacturing licence applications for Class A and Class B
devices generally fall under the relevant State Licensing
Authority route, subject to the current rules and any
applicable exemption.
The applicable application form, manufacturing site records,
quality management documentation and assessment requirements
should be verified before submission.
Manufacturing - Class C and D
Manufacturing licence applications for Class C and Class D
devices generally fall under the Central Licensing Authority
through CDSCO.
The application may require detailed technical information,
quality management evidence and other documents prescribed
for the relevant device and application type.
Import of Medical Devices
Import licensing for medical devices is generally handled
through CDSCO under the applicable import provisions.
Importer details, overseas manufacturer information, product
particulars and prescribed supporting documents may be required.
Sale and Distribution
Sale, stock, exhibition for sale and distribution requirements
must be assessed for the applicable activity and premises.
Confirm the relevant State or Union Territory Licensing
Authority requirements and any applicable premises registration
or licensing conditions.
Documents Required for Medical Device Registration
The final checklist depends on the application type, device risk class,
applicant role, manufacturing site and applicable regulatory pathway.
The documents below are indicative and are not a universal checklist.
Business and Applicant Documents
- Entity incorporation or constitution documents, where applicable
- PAN and applicant identification details
- Registered office and manufacturing site details
- Authorisation letter or board resolution, where required
- Details of the authorised signatory
- Existing applicable licences and registrations
Product and Device Information
- Device name, model and product description
- Intended use and indications
- Device classification rationale, where required
- Product specifications and configuration details
- Labels, packaging and instructions for use, as applicable
- Manufacturer and manufacturing site information
Technical and Quality Records
- Applicable technical dossier documents
- Risk management records, where required
- Verification, validation or performance evidence, as applicable
- Quality management system documentation
- Test reports and standards-related evidence, where required
- Post-market and vigilance procedures, as applicable
Import and Overseas Manufacturer Records
- Overseas manufacturer details
- Authorisation documents, where prescribed
- Applicable free sale or regulatory certificates
- Product and manufacturing site details
- Prescribed declarations and undertakings
- Other documents required by the applicable import checklist
Quality Management and Technical Documentation
Medical device applications may require evidence relating to product
safety, performance, quality management, risk management and manufacturing
controls. The exact requirements depend on the device and regulatory route.
Quality Management System
Identify applicable quality management system requirements
and organise available certificates, procedures and records.
Product Safety and Performance
Coordinate relevant product specifications, test evidence,
verification and validation records with the manufacturer's
technical team.
Risk Management
Identify applicable risk management documentation needs and
coordinate the relevant records prepared by qualified
technical personnel.
Labelling and Instructions
Organise applicable labelling, packaging and instructions
for use for review against the requirements relevant to
the device.
Our Medical Device Registration Process
01
Initial Consultation
Collect details about the product, applicant, intended use,
business activity and manufacturing or import arrangements.
02
Regulatory Route Assessment
Identify the classification and application pathway to be
verified against current official rules and guidance.
03
Document Checklist
Prepare an application-specific checklist and identify
documents that need to be collected or updated.
04
Application Preparation
Assist with organising prescribed forms and supporting
documents within the agreed scope of work.
05
Submission Coordination
Coordinate the submission process and help organise responses
to document-related queries where agreed.
06
Post-Submission Follow-Up
Help track correspondence and organise records relating to
the application, subject to the agreed service scope.
ASSESS | DOCUMENT | APPLY
Planning to Launch or Import a Medical Device?
Share the product name, intended use, manufacturer details,
risk class if known, and whether the application concerns
manufacturing, importing or sale and distribution. This
information helps establish the initial documentation checklist
and the regulatory questions that need to be verified.
Frequently Asked Questions
1. Which rules govern medical devices in India?
Medical devices are regulated under the Drugs and Cosmetics Act,
1940 and the Medical Devices Rules, 2017, along with applicable
amendments, notifications and directions.
2. What are the four medical device risk classes?
The broad risk categories are Class A (low risk), Class B
(low to moderate risk), Class C (moderate to high risk) and
Class D (high risk). The classification of a particular product
must be verified against the applicable rules and guidance.
3. Is CDSCO approval required for every medical device?
The applicable regulatory route depends on the device, activity
and current rules. Import licensing and certain manufacturing
licences are handled by the Central Licensing Authority, while
other activities fall under State or Union Territory authorities.
Any specific exemption must be verified before relying on it.
4. Who grants manufacturing licences for medical devices?
Broadly, the relevant State Licensing Authority handles
manufacturing licences for Class A and Class B devices, while
the Central Licensing Authority handles Class C and Class D
manufacturing licences, subject to current rules and applicable
exceptions.
5. Which authority handles medical device import licences?
Import licensing for medical devices is generally handled by
CDSCO under the Medical Devices Rules, 2017. The application
requirements should be checked for the particular device and
import arrangement.
6. Is ISO 13485 certification required?
Quality management system requirements depend on the applicable
regulatory route and device category. ISO 13485 is a recognised
medical device quality management standard, but whether a
particular certificate or form of evidence is required must be
checked against the current regulatory requirements.
7. What documents are required?
Documents may include applicant details, product specifications,
intended use, manufacturer information, labels, technical
documentation, quality records and other prescribed evidence.
The final checklist depends on the application type and device.
8. Can an importer apply for a medical device licence?
An eligible applicant may apply through the applicable import
licensing route, subject to the prescribed requirements and
supporting documentation.
9. How long does medical device registration take?
Processing time depends on the application pathway, completeness
of the submission, technical review, inspections or audits where
applicable, and any clarification requests. A fixed approval
timeline cannot be guaranteed.
10. Does BBSR Services guarantee a licence?
No. BBSR Services can assist with documentation and application
coordination within the agreed scope. The competent licensing
authority makes the regulatory decision.
BBSR SERVICES | MEDICAL DEVICE BUSINESS SUPPORT
Start Your Medical Device Registration Assessment
Get help organising your initial product information, application
documents and regulatory questions. Contact BBSR Services to discuss
the requirements relevant to your medical device business.
Disclaimer: This page provides general information
and describes documentation assistance. It is not legal, clinical,
engineering or regulatory advice. Medical device classification,
exemptions, licensing routes and document requirements must be
verified against the latest applicable legislation, CDSCO guidance
and directions of the competent authority. No licence, approval or
processing timeline is guaranteed.