BIS Scheme-I certification for the Indian market.
The Bureau of Indian Standards mandates Scheme-I certification for a growing list of medical devices before they can be sold in India. We manage the complete BIS process — from pre-application testing strategy to factory inspection readiness and licence issuance.
BIS Scheme-I (Conformity Assessment Scheme) mandates that products listed under Quality Control Orders be certified before sale in India. For medical devices, the relevant QCOs apply to specific categories including pulse oximeters, blood pressure monitors, thermometers, and other devices notified under the Medical Devices (Quality Control) Orders. Products sold without a valid BIS licence attract seizure and prosecution under the BIS Act 2016.
The scheme requires product testing to the applicable IS (Indian Standard), which in most cases harmonises with or directly adopts the corresponding IEC or ISO standard. Following satisfactory testing, BIS conducts a factory inspection at the manufacturing premises — either in India or, for foreign manufacturers, at the overseas facility. The BIS licence is then granted for a specific product and manufacturing site, and is subject to annual surveillance inspections.
Foreign manufacturers must appoint an Authorised Indian Representative (AIR) who holds the licence jointly. The AIR bears legal responsibility for product conformity in India. We advise on AIR selection and structure the appointment correctly to ensure BIS accepts the arrangement.
Review of applicable QCOs, identification of required IS standards, gap analysis against your existing test data, and testing strategy to avoid duplicate testing.
Identification of BIS-recognised test laboratories, preparation of samples and test instructions, and coordination of testing to applicable IS standards.
Pre-inspection documentation pack, process walkthrough against BIS inspection checklist, and coaching for manufacturing team on what inspectors assess.
Complete application preparation including Form-I, technical schedule, AIR appointment documents, and liaison with BIS regional office through to licence grant.
IS standards for medical devices are maintained by BIS Technical Committee MHD and are largely aligned with IEC and ISO counterparts. For example, IS 13450 aligns with IEC 60601-1 for electromedical equipment, while IS 14408 covers clinical thermometers. Where a product has existing IEC/EN test reports, we assess clause-by-clause equivalence and identify any IS-specific additions that require incremental testing.
BIS-recognised laboratories are mandatory for tests cited in the BIS licence application. We identify the most efficient accredited laboratory for each test type, prepare the laboratory instruction package, review draft reports before they are submitted to BIS, and manage any corrective retesting. Test reports have a validity period for BIS purposes; we track expiry against certification renewal timelines.
Clause-by-clause comparison of your existing IEC/ISO test reports against the applicable IS standard, identifying tests that can be bridged and those requiring fresh testing.
Identification of BIS-recognised labs with the required scope, preparation of test instructions, and sample coordination.
Technical review of draft test reports before submission to BIS, checking for deficiencies that would cause BIS to raise objections.
A BIS Scheme-I licence requires annual surveillance inspections and periodic renewal. During surveillance, BIS inspectors verify continued conformity of the product on the market to the IS standard and check that the manufacturing process has not changed materially. Licence conditions must be met at all times — changes to product design, manufacturing location, or key materials require prior BIS notification and may trigger a fresh inspection or testing cycle.
We provide ongoing BIS licence management, covering inspection preparation for each surveillance visit, change notification filings, and renewal applications. We also advise when product modifications require a fresh or amended licence rather than a minor change notification.
Annual inspection readiness review, documentation update, and manufacturing team briefing before each BIS surveillance visit.
Assessment of proposed product or process changes against BIS licence conditions and filing of change notifications or fresh applications as required.
Timely preparation and submission of BIS licence renewal applications, with proactive tracking against expiry dates.
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