In Vitro Diagnostic (IVD) Device Manufacturing Licence

Overview of In Vitro Diagnostic (IVD) Device Manufacturing Licence

An In Vitro Diagnostic (IVD) Device Manufacturing Licence is mandatory for manufacturing IVD devices, kits, reagents, and systems in India. These products are used to examine specimens collected from the human body for the diagnosis, screening, monitoring, or detection of diseases and other health conditions.

The manufacturing of IVD devices is regulated under the Medical Devices Rules, 2017, read with the Drugs and Cosmetics Act, 1940. Depending on the risk classification of the IVD device, the manufacturing licence is granted by the State Licensing Authority (SLA) or the Central Licensing Authority (CLA).

Classification of IVD Devices

Under the Medical Devices Rules, 2017, IVD devices are classified into four risk-based categories:

The applicable regulatory requirements and licensing authority depend on the risk classification of the IVD device.

Common Types of IVD Devices

Examples of In Vitro Diagnostic devices include:

• HIV diagnostic kits

• Hepatitis B (HBV) diagnostic kits

• Hepatitis C (HCV) diagnostic kits

• Blood grouping reagents and sera

• Clinical chemistry reagents

• Molecular diagnostic kits

• Immunoassay and rapid diagnostic test kits

Regulatory Authorities for IVD Device Manufacturing

State Licensing Authority (SLA)

The State Licensing Authority (SLA) issues manufacturing licences for Class A and Class B IVD devices. Applicants must submit the prescribed application and supporting documents to the concerned State Licensing Authority.

Central Licensing Authority (CLA)

The Central Licensing Authority (CLA), functioning through CDSCO, grants manufacturing licences for Class C and Class D IVD devices. The authority reviews technical documentation and may inspect the manufacturing facility before granting approval.

Application Forms for Medical Device & IVD Manufacturing Licences

The applicable application and licence forms under the Medical Devices Rules, 2017 depend on the type of licence and the risk classification of the medical device or IVD.

Applicants should ensure that the correct application form is used based on the device classification and the type of licence being sought. The licensing process is governed by the Medical Devices Rules, 2017, and the licence is issued by the appropriate State Licensing Authority (SLA) or Central Licensing Authority (CLA).

Documents Required for an In Vitro Diagnostic (IVD) Device Manufacturing Licence

The following documents are generally required to apply for an IVD Device Manufacturing Licence in India:

• Covering letter.

• Duly filled application form in the prescribed format.

• Government fee payment challan/receipt.

• Business constitution documents, such as:

  • Certificate of Incorporation, Memorandum & Articles of Association (Company)

  • LLP Agreement (LLP)

  • Partnership Deed (Partnership Firm)

  • Proprietorship proof (Proprietorship)

• Details and identity/address proof of the proprietor, partners, directors, or authorised signatory.

• Proof of ownership, lease deed, or rent agreement for the manufacturing premises.

• Site layout plan and manufacturing facility details.

• Plant Master File (PMF) and Device Master File (DMF), wherever applicable.

• Details of the Manufacturing Chemist and Analytical Chemist, including educational qualifications, experience certificates, appointment letters, and declarations.

• List of manufacturing equipment, testing facilities, and quality control infrastructure.

• Performance Evaluation Report, where applicable.

• Test Licence, if applicable.

• Declaration confirming compliance with the applicable provisions of the Medical Devices Rules, 2017 and Good Manufacturing Practices (GMP).

• Any additional documents required by the State Licensing Authority (SLA) or Central Licensing Authority (CLA).

Additional Documents for Loan Licence

If applying for an IVD Loan Licence, the following documents may also be required:

• Consent letter from the principal manufacturer.

• Valid manufacturing licence of the principal manufacturer.

• Wholesale licence of the applicant, where applicable.

• Product permissions and supporting documents relating to the products proposed to be manufactured.

Procedure for Obtaining an In Vitro Diagnostic (IVD) Device Manufacturing Licence

The process for obtaining an IVD Device Manufacturing Licence in India generally involves the following steps:

Step 1: Application Submission

Submit the prescribed application form along with the required documents and government fee to the appropriate State Licensing Authority (SLA) or Central Licensing Authority (CLA), depending on the risk classification of the IVD device.

Step 2: Document Verification

The licensing authority reviews the application and supporting documents. If any discrepancies or additional information are required, the applicant is asked to provide the necessary clarification or documents.

Step 3: Inspection of Manufacturing Facility

The manufacturing premises may be inspected by the competent authority or a notified body to verify compliance with the Medical Devices Rules, 2017, Quality Management System (QMS), and Good Manufacturing Practices (GMP).

Step 4: Technical Evaluation

The authority evaluates the product specifications, manufacturing process, quality control measures, and technical documentation to ensure regulatory compliance.

Step 5: Compliance Review

After successful inspection and technical evaluation, the licensing authority confirms that all regulatory requirements have been fulfilled.

Step 6: Grant of Manufacturing Licence

Once the application satisfies all applicable requirements, the In Vitro Diagnostic (IVD) Device Manufacturing Licence is issued, authorising the legal manufacture and sale of IVD devices in India.