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The Indian medical device landscape is undergoing a significant regulatory shift. The Central Drugs Standard Control Organization (CDSCO) has recently released a new draft guidance document (2026) specifically for the import of In-Vitro Diagnostic (IVD) medical devices.
This 32-page document serves as a roadmap for importers, aiming to streamline the approval process through the "cdscomdonline" and National Single Window System (NSWS) portals.
One of the most critical distinctions in the guidance is the application type. If you are importing devices for commercial sale, you must use Form MD-14 to obtain an MD-15 license. However, if the import is for testing, evaluation, or clinical investigation, Form MD-16 (leading to an MD-17 license) is required.
The timeline for approval varies significantly: 270 days for MD-14 applications compared to just 30 days for MD-16.
The CDSCO has highlighted that technical errors are a leading cause of delays. For instance, the Power of Attorney (POA) must be co-jointly signed and stamped by both the foreign manufacturer and the Indian agent.
Discrepancies between the product name on the POA and the Free Sale Certificate (FSC) can lead to immediate queries.
Furthermore, ISO 13485 (QMS) certificates must be valid, notarized, and submitted for both legal and actual manufacturers.
For high-risk or critical diagnostic kits (such as those for HIV, Cancer, or Malaria), the guidance mandates a Performance Evaluation Report (PER) from a CDSCO-registered laboratory. This ensures that the sensitivity and specificity of the devices are verified within the Indian context before they reach the market.
The move toward the NSWS portal for test licenses (MD-16) and the MD Online Portal for commercial licenses (MD-14) reflects the government’s commitment to "Ease of Doing Business". By providing a granular checklist—from covering letters to site master files—the CDSCO is empowering stakeholders to submit "right-first-time" applications.
This document is currently in a draft stage. Stakeholders are encouraged to provide feedback via the official Google Form within 15 days of publication to help shape the final regulatory framework.
By adhering to these updated guidelines, importers can ensure timely approvals and contribute to the availability of high-quality diagnostic tools in the Indian healthcare system.
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