Importer | Source: CDSCO
Published On: 02-02-2026
Enforcement Date: 02 February, 2026
Draft Guidance document for Import of In-vitro diagnostic Medical device for stakeholders comment (dated 30.01.2026)
The Central Drugs Standard Control Organization (CDSCO) has issued a Draft Guidance Document outlining procedures for import of In-Vitro Diagnostic (IVD) medical devices under the Medical Devices Rules, 2017. The document details classification, application pathways (MD-14, MD-16), documentation requirements, performance evaluation norms, and regulatory timelines. Stakeholders are invited to submit comments before finalisation to streamline and strengthen the IVD import approval process.
The Central Drugs Standard Control Organization (CDSCO) has released a Draft Guidance Document for the import of In-Vitro Diagnostic (IVD) medical devices under the Medical Devices Rules, 2017.
Key points include:
- The guidance provides comprehensive clarity on regulatory pathways, including application procedures through Forms MD-14 and MD-16, risk-based classification (Class A, B, C, and D), and associated review timelines.
- It specifies detailed documentation requirements such as Device Master File (DMF), Plant Master File (PMF), ISO 13485 certification, Free Sale Certificate, performance evaluation reports, stability data, and post-market surveillance obligations.
- Special provisions are included for critical IVDs requiring performance evaluation in India.
- The draft aims to improve application completeness, ensure regulatory consistency, and enhance transparency in the approval process.
- CDSCO has invited stakeholder comments prior to finalisation of the guidance to support effective implementation and ease of compliance for importers.
Applicable For: Importer
Reference Number: No.CDSCO/IVD/GD/DRAFT/IMP/01/2026
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