When buying respiratory equipment in India, ask for documents that identify the exact device and the business responsible for supplying it. A familiar logo, an overseas mark or a reassuring sales description is not enough to establish that a particular unit meets the applicable Indian requirements.
Start with the product identity
Compare the manufacturer, model and serial or batch information on the device, packaging, invoice and instructions. Ask the supplier to explain discrepancies before accepting the equipment. Keep copies of the invoice, warranty terms, prescription where relevant, and contact details for service.
The documentation should match the device being supplied, not simply a similar product or another model from the same manufacturer. A brochure is useful for understanding features, but it is not the same as a regulatory document or the instructions for use.
Understand the Indian framework
The Medical Devices Rules, 2017 provide India's risk-based framework. CDSCO and State Licensing Authorities have different responsibilities. The applicable route depends on the device, intended use, risk classification and activity, such as manufacture, import or sale. Exceptions and subsequent notifications also matter.
Ask for the relevant import or manufacturing licence and its device coverage, where required, and for the seller's applicable registration or licence details. Do not assume that every respiratory product has the same classification. For a disputed or unclear case, confirm the requirement through current CDSCO information or the relevant licensing authority.
CDSCO's public guidance distinguishes regulatory compliance from a separate ISO certificate: an ISO 13485 certificate alone is not product authorisation, and the requirement to meet a quality system should not be confused with a universal requirement to hold that certificate.
Different documents answer different questions
CE marking concerns conformity with applicable European requirements. An FDA clearance or approval concerns a specific US regulatory pathway. Neither automatically establishes permission to supply the product in India. Conversely, a device does not need every foreign mark simply because it is sold here.
Avoid treating the phrase “internationally approved” as a precise claim. Ask which authority, which document and which exact model it refers to. A certificate for a company's processes does not necessarily cover the performance claims made for each product.
Warranty and service need their own checks
Regulatory status does not determine every warranty term. Obtain written confirmation of warranty coverage, service location, spare-part availability and who handles a fault. Imported products may have different local support arrangements; verify them with the responsible supplier rather than assuming coverage from a global warranty statement.
If documents cannot be confirmed, pause the purchase and seek clarification. Missing information is a reason to investigate, not enough on its own to diagnose counterfeiting or declare a particular transaction unlawful. For a safety incident, preserve the device details and contact the treating team and the appropriate reporting authority.