\n| \n New IVD forms<\/span><\/p>\n<\/td>\n | \n MD-28 (application), MD-29 (permission)<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/span>What Is CDSCO Registration for Lab Equipment & Diagnostic Devices?<\/b><\/span><\/h2>\nIt’s the mandatory clearance from the Bureau’s drug regulator that permits manufacturing, import, or sale of laboratory instruments and in-vitro diagnostic devices in India. That covers diagnostic kits, reagents, analyzers, and the instruments that run them, all under the same Medical Devices Rules, 2017 framework, though the specific classification and licensing path differs by device type and risk level.<\/span><\/p>\n<\/span>Which Lab Equipment and Diagnostic Devices Require CDSCO Compliance?<\/b><\/span><\/h2>\nAlmost anything used for diagnosis, from a simple rapid test strip to a full molecular sequencing platform, falls under this net today.<\/span><\/p>\n\n- Diagnostic reagent kits and test strips<\/span><\/li>\n
- Blood and specimen collection tubes<\/span><\/li>\n
- Diagnostic analyzers and instruments<\/span><\/li>\n
- Software driving or interpreting diagnostic results<\/span><\/li>\n
- Point-of-care testing devices<\/span><\/li>\n
- Laboratory testing equipment used specifically for in-vitro diagnosis<\/span><\/li>\n<\/ul>\n
<\/span>CDSCO Classification of Medical Devices and IVDs<\/b><\/span><\/h2>\nClassification decides your entire regulatory path, and IVDs follow their own specific rule within the broader framework.<\/span><\/p>\nRule 4 of the Medical Devices Rules, 2017 sets out four risk classes for IVDs, A through D, based on intended use and criteria under Part II of the First Schedule. The Central Licensing Authority classifies every IVD centrally, regardless of which authority eventually issues the manufacturing licence. A specimen collection tube, for instance, sits in Class A under this framework, while a molecular diagnostic kit for a serious infectious disease typically lands in Class C or D given the clinical stakes involved.<\/span><\/p>\nCDSCO tightened this further with an October 2025 directive to State Licensing Authorities, making clear that no IVD licence can be issued for a device that hasn’t first cleared central classification. That closed a gap where some SLAs had, in practice, licensed products without confirming classification through the CLA first. Since then, classification genuinely has to come before licensing, not alongside it or as an afterthought during examination.<\/span><\/p>\n<\/span>CDSCO Registration vs CDSCO License: What Is the Difference?<\/b><\/span><\/h2>\nThese terms get used loosely, and the distinction matters more than people assume. Registration, in the lighter sense CDSCO uses for certain lower-risk categories, involves less scrutiny and no mandatory factory inspection. A full manufacturing licence, required for higher-risk IVDs and most lab equipment falling under Class C or D, involves detailed technical review and often a site inspection before approval.<\/span><\/p>\n<\/span>Who Can Apply for CDSCO Registration\/Approval?<\/b><\/span><\/h2>\nIndian manufacturers apply directly through the SUGAM portal. Foreign manufacturers without an Indian legal presence must appoint an Authorised Indian Representative to file on their behalf, since CDSCO doesn’t accept applications from entities without a legal footprint in India. Laboratories themselves, seeking to conduct IVD performance evaluation on behalf of a manufacturer, apply separately for their own registration too.<\/span><\/p>\n<\/span>CDSCO Registration Process for Lab Equipment & Diagnostic Devices<\/b><\/span><\/h2>\nThe process runs through a handful of stages, and the exact route depends on whether your product already has a published classification.<\/span><\/p>\n<\/span>Step 1: Confirm the Device Classification<\/b><\/span><\/h3>\nCheck the product against CDSCO’s published IVD classification list before doing anything else.<\/span><\/p>\n<\/span>Step 2: Use the Risk-Classification Module If Unlisted<\/b><\/span><\/h3>\nFor a device with no existing classification, submit intended use, technology, and device principle details through CDSCO’s Risk-Classification Module.<\/span><\/p>\n<\/span>Step 3: Arrange Performance Evaluation<\/b><\/span><\/h3>\nGet the device tested at a CDSCO-recognised laboratory for IVD performance evaluation.<\/span><\/p>\n<\/span>Step 4: File the Application<\/b><\/span><\/h3>\nSubmit through SUGAM, using the appropriate form based on classification and manufacturing route.<\/span><\/p>\n<\/span>Step 5: Respond to Review Queries<\/b><\/span><\/h3>\nAddress any technical or documentation queries CDSCO raises during examination.<\/span><\/p>\n<\/span>Step 6: Receive the Licence or Permission<\/b><\/span><\/h3>\nOnce approved, you receive your licence number or, for a genuinely new IVD, Form MD-29 permission.<\/span><\/p>\n<\/span>Documents Required for CDSCO Registration<\/b><\/span><\/h2>\n\n\n\n| \n Document<\/b><\/p>\n<\/td>\n | \n Purpose<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n Device Master File<\/span><\/p>\n<\/td>\n | \n Technical details of the product<\/span><\/p>\n<\/td>\n<\/tr>\n\n| \n Performance evaluation report<\/span><\/p>\n<\/td>\n | \n From a CDSCO-recognised testing laboratory<\/span><\/p>\n<\/td>\n<\/tr>\n\n| \n Intended use and classification justification<\/span><\/p>\n<\/td>\n | \n Confirms Rule 4 classification claimed<\/span><\/p>\n<\/td>\n<\/tr>\n\n| \n Constitution\/incorporation documents<\/span><\/p>\n<\/td>\n | \n Confirms applicant’s legal identity<\/span><\/p>\n<\/td>\n<\/tr>\n\n| \n Authorised Indian Representative agreement<\/span><\/p>\n<\/td>\n | \n Required for foreign manufacturers<\/span><\/p>\n<\/td>\n<\/tr>\n\n | | | | | | |
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