Key Medical Device Licenses in India

1. Manufacturing License for Class A & Class B Medical Devices

Applicable Forms: Form MD-3 / Form MD-5

A manufacturing license is required for companies intending to manufacture Class A or Class B medical devices in India.

The application is generally submitted in Form MD-3, and the license is granted in Form MD-5.

Common requirements include:

• Device master file
• Site master file
• Quality management system documents
• Manufacturing site details
• Product specifications
• Labels and instructions for use
• ISO 13485 certificate, wherever applicable
• Performance and safety data

This license is generally handled by the State Licensing Authority.

2. Manufacturing License for Class C & Class D Medical Devices

Applicable Forms: Form MD-7 / Form MD-9

For higher-risk devices falling under Class C and Class D, the application is submitted in Form MD-7, and the license is granted in Form MD-9.

These devices are generally reviewed more stringently due to their risk profile and intended use.

Common requirements include:

• Detailed device master file
• Clinical evaluation data
• Risk analysis report
• Performance evaluation data
• Sterilization validation, wherever applicable
• Biocompatibility data, wherever applicable
• Quality management system documents
• Plant master file
• Technical documentation

This license is handled by the Central Licensing Authority, generally CDSCO.

3. Loan License for Manufacturing Medical Devices

Applicable Forms: For Class A & B: Form MD-4 / Form MD-6 · For Class C & D: Form MD-8 / Form MD-10

A loan license is applicable when a company wants to manufacture medical devices using the manufacturing facility of another licensed manufacturer.

This model is common for brand owners, marketers, and companies that do not own their own manufacturing facility but wish to manufacture products through a third-party licensed unit.

Key considerations:

• Agreement with licensed manufacturer
• Product responsibility
• Technical documentation
• Labeling responsibility
• Quality and compliance control
• Site and product approval

4. Import License for Medical Devices

Applicable Forms: Form MD-14 / Form MD-15

An import license is required for importing medical devices and IVDs into India. The application is submitted in Form MD-14, and the import license is granted in Form MD-15.

This is one of the most important approvals for global manufacturers, Indian importers, authorized agents, and distributors planning to bring medical devices into India.

Common requirements include:

• Free Sale Certificate
• ISO 13485 certificate
• CE certificate / regulatory approval from reference countries, wherever applicable
• Power of Attorney from foreign manufacturer
• Plant master file
• Device master file
• Labels and IFU
• Performance and safety data
• Undertaking and authorization documents

5. Registration of Medical Devices by Importers

In certain cases, medical devices may require registration or import-related compliance before commercial sale in India. Importers must ensure that the product is correctly classified and that all applicable licensing requirements are fulfilled before shipment or distribution.

Importers should verify:

• Device classification
• Notified / regulated status
• Applicable license requirement
• Labelling compliance
• Authorized agent requirement
• Post-import responsibilities

6. Test License for Medical Devices

Applicable Forms: Form MD-12 / Form MD-13

A test license is required for importing or manufacturing medical devices in small quantities for purposes such as testing, evaluation, demonstration, training, or clinical investigation.

The application is submitted in Form MD-12, and the license is granted in Form MD-13.

Common use cases:

• Product evaluation
• Performance testing
• Demonstration samples
• Training samples
• Clinical investigation support
• Research and development

A test license does not permit routine commercial sale.

7. Clinical Investigation Permission

Medical devices that require clinical investigation in India may need permission from the Central Licensing Authority.

This is generally applicable where sufficient clinical data is not available, or where the product is novel, high-risk, or requires India-specific clinical evaluation.

Key requirements may include:

• Clinical investigation plan
• Ethics committee approval
• Investigator details
• Risk analysis
• Subject safety documents
• Informed consent documents
• Device safety and performance data

8. IVD Manufacturing and Import Licenses

In-vitro diagnostic devices are also regulated under the Medical Devices Rules, 2017.

IVDs may include:

• Diagnostic kits
• Reagents
• Rapid test kits
• Analyzers
• Blood glucose monitoring systems
• Molecular diagnostic kits
• ELISA kits
• Clinical chemistry kits

Licensing requirements depend on classification, intended use, and whether the product is manufactured in India or imported.

Important Documents Required for Medical Device Licensing

Although documentation may vary depending on device class and license type, common documents include:

• Device master file
• Plant master file / site master file
• ISO 13485 certificate
• Constitution documents of applicant
• Manufacturing site details
• Product specifications
• Labels and instructions for use
• Risk analysis report
• Performance evaluation report
• Clinical evidence / clinical evaluation report
• Sterilization validation, wherever applicable
• Biocompatibility data, wherever applicable
• Shelf-life and stability data
• Free Sale Certificate for import cases
• Power of Attorney for foreign manufacturers
• Quality management system documents