CDSCO Issues Draft Guidance for Manufacturing In-Vitro Diagnostic Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Ministry of Health and Family Welfare, has reportedly issued a draft document titled “Guidance Document for Manufacturers for In-Vitro Diagnostic Medical Device” dated 9 October 2026.

The draft aims to help domestic manufacturers prepare and submit IVD medical device manufacturing licence applications through the designated online portals. It explains application requirements, supporting documents, device classification, licensing pathways, inspection requirements and regulatory timelines.

1. Scope and Applicability

The draft primarily addresses domestic manufacturers seeking licences for IVD medical devices used to examine human or animal specimens. Examples include:

• Diagnostic reagents, calibrators and control materials
• Specimen receptacles and diagnostic test kits
• Instruments, analysers and associated apparatus
• Relevant software and components intended for in-vitro examination of specimens

These products may be intended for diagnosis, screening, monitoring, prognosis, prediction or assessment of physiological conditions and compatibility. The guidance covers test licences, fresh manufacturing licences, loan licences, endorsements of additional devices and retention of existing licences.

2. Risk Classification of IVD Medical Devices

Risk classification is a key factor in selecting the regulatory pathway and licensing authority under the Medical Devices Rules, 2017.

Manufacturers should determine the classification based on intended purpose and applicable parameters under Part II of the First Schedule of the Medical Devices Rules, 2017. Check the latest classification lists and CDSCO notices before filing.

3. Manufacturing Licence Categories and Application Forms

Test licence under Form MD-12

This pathway is intended for limited quantities manufactured for specified non-commercial purposes. Applicants should justify the quantity, describe the intended activities and testing arrangements, and ensure the products are not intended for commercial sale.

Other licence pathways

A fresh licence may be required for a new facility or first-time manufacturing, subject to the applicable rules. Endorsement procedures apply when adding devices to an existing licence. A loan licence may allow eligible manufacturing using another licensee's site, subject to regulatory requirements.

4. Online Portals for Application Submission

The draft identifies the CDSCO Online System for Medical Device and the National Single Window System (NSWS) for relevant applications. According to the supplied document, Forms MD-3, MD-4, MD-7 and MD-8 and specified related processes are handled through the CDSCO online system, while Form MD-12 applications are submitted through NSWS.

Applicants should check current portal instructions, applicable fees and document requirements before submission.

5. Key Documents Required for Manufacturing Licence Applications

Form MD-12 applications

• Covering letter on company letterhead
• IVD device description, design, construction materials and intended use
• Raw-material source quality certificates, where applicable
• Undertaking on availability of manufacturing facilities, equipment, instruments and personnel
• Equipment and instrument list
• Qualified personnel details, qualifications, experience and responsibilities
• Justification for proposed manufacturing quantity
• Test protocol, where applicable
• Existing site manufacturing licence details, where applicable
• R&D authorisation or supporting documents, where applicable
• Other relevant documents and fee-payment evidence
• Completed and digitally signed Form MD-12

The proposed quantity should be supported by intended testing, performance evaluation, verification or validation activities. Where testing uses external sites, the quantity allocation should be clearly explained.

Forms MD-7 and MD-8 applications

For Class C and Class D devices, the draft lists important materials including:

• Device Master File (DMF) and Plant Master File (PMF)
• Essential Principles Checklist
• Risk management documentation and mitigation measures
• Device verification and validation data
• Analytical and, where applicable, clinical performance evaluation evidence
• Performance Evaluation Report, where required
• Labelling, Instructions for Use (IFU) and product information
• Manufacturing, quality-control and personnel details
• Quality Management System documentation
• Relevant inspection or audit reports, certificates, permissions and fee evidence

6. Intended Use and Product Information

Product information should be clear and consistent throughout the application and supporting documents. Manufacturers should document:

• Generic and, where applicable, brand name
• Model or catalogue number
• Intended use and clinical purpose
• Analyte or biomarker
• Specimen type and relevant additives
• Intended user and target population
• Human or animal species, as applicable
• Testing method and principle of operation
• Relevant instruments or analyser platforms
• Sterile or non-sterile status, where applicable
• Labelling, packaging and IFU information

Inconsistencies in product names, intended-use claims, model numbers or specimen details may lead to clarification requests. The supplied draft also cautions against certain special characters in specific Form MD-12 fields and recommends expanding acronyms.

7. New IVD Devices and Substantial Equivalence

Manufacturers should assess whether a similar device approved by the Central Licensing Authority exists. Relevant characteristics may include specimen, technology, operating principle, composition and intended use. Where a similar device exists, supporting information for the claimed substantial equivalence may be required.

For products meeting the definition of a new IVD medical device under the Medical Devices Rules, 2017, the supplied guidance indicates that applicable permissions under Forms MD-25 and MD-29 must be obtained before proceeding with the relevant manufacturing licence application. Confirm the applicable pathway against the official rules and final guidance.

8. Performance Evaluation, Verification and Validation

Manufacturers should document performance characteristics relevant to the device's intended purpose and associated risks. Depending on the device, this may include:

• Accuracy or trueness
• Precision and repeatability
• Analytical sensitivity and specificity
• Limit of detection and limit of quantitation, where relevant
• Interference and cross-reactivity
• Measuring range and assay cut-off
• Stability, including shelf life, in-use and shipping stability
• Clinical performance evidence, where applicable

Where clinical performance evaluation is required, ensure relevant permissions, study arrangements, protocols and supporting evidence are in place before undertaking the applicable activities.

9. Quality Management System and Manufacturing-Site Readiness

The draft highlights the importance of a functioning Quality Management System (QMS) and compliance with applicable manufacturing requirements. Manufacturers should maintain appropriate arrangements for:

• Manufacturing and quality-control processes
• Equipment calibration and maintenance
• Personnel competence and training
• Production and testing records
• Non-conforming product control
• Complaint handling and corrective and preventive action (CAPA)
• Vigilance reporting, recalls and post-market surveillance
• Risk management and technical documentation

An ISO 13485 certificate may be relevant supporting documentation where available, but it should not be assumed to replace other applicable regulatory requirements. Class C and D sites should be prepared for the inspection required under the applicable provisions.

10. Regulatory Timelines and Inspection Requirements

The draft guidance specifies the following application-processing timelines:

These timelines are reported as stated in the draft and should be interpreted in the context of the applicable Rules and the relevant application process.

Manufacturing-site inspections

• Class A: A pre-grant audit is generally not required under the pathway described; the audit by a registered Notified Body is to be conducted within 120 days from licence grant.
• Class B: The audit by a registered Notified Body is to be conducted within 90 days from the application date.
• Class C and D: The site is to undergo inspection within 60 days from the application date under the provisions described in the draft.

Confirm the applicable requirements under the Medical Devices Rules, 2017 and any subsequent amendments or official clarifications.

11. Validity and Retention of Manufacturing Licences

The supplied draft states that a manufacturing licence remains valid in perpetuity, subject to payment of the applicable retention fee before completion of five years from the issue date and submission of the required information and documents.

Manufacturers should add retention deadlines to their regulatory compliance calendar and verify the retention status of an existing licence before applying for an endorsement where relevant.

12. What IVD Manufacturers Should Do Now

• Review device classification against the latest CDSCO information.
• Select the correct test, fresh, loan, endorsement or retention pathway.
• Conduct a documentation gap assessment for DMF, PMF, risk files, performance evidence, labelling and QMS records.
• Standardise product names, intended use, model numbers, specimen types and claims.
• Assess gaps in analytical performance, stability, verification, validation and clinical performance documentation.
• Prepare the manufacturing facility, equipment, personnel, records and QMS for regulatory assessment.
• Confirm the current portal, application form, fee and checklist before filing.
• Review the draft and consider submitting reasoned stakeholder comments within the consultation period.

Conclusion

The CDSCO draft guidance dated 9 October 2026 provides a structured reference for domestic manufacturers seeking IVD medical device manufacturing licences in India. Its key focus areas include risk-based licensing, application-specific documentation, performance evaluation, quality management, site inspections and licence retention.

Manufacturers should establish a clear regulatory pathway and prepare a complete, internally consistent technical dossier before submission. Because the document is a draft for stakeholder consultation, monitor official CDSCO updates and verify the final requirements after consultation and any subsequent revisions.

Reference: CDSCO draft guidance, “Guidance Document for Manufacturers for In-Vitro Diagnostic Medical Device,” reference CDSCO/IVD/GD/DRAFT/MFG/01/2026, dated 9 October 2026.

Disclaimer: This article is based on the supplied draft guidance details and is for general regulatory awareness. It is not legal advice and does not replace the Medical Devices Rules, 2017, subsequent amendments or official regulatory clarifications.