Indian Army Hearing Aid Tender GWALIOR Madhya Pradesh Behind the Ear Digital Hearing Aid MDR 2017 IS 16127 2026

Bidders must submit MDR 2017 compliance evidence and a valid Medical License under the Drugs and Cosmetic Act, along with IS 16127 conformity. Include OEM authorizations if applicable, GST, PAN, and experience certificates. Ensure IS 16127 packing and dimensions are met; delivery terms follow the ±25% quantity option.

Required documents include GST registration, PAN, experience certificates in medical devices, financial statements, medical license proof, MDR compliance certificates, and OEM authorization. Technical bid must demonstrate IS 16127 conformity and packaging standards; submit EMD proof if demanded by the procurement terms.

Standards include MDR 2017 compliance, IS 16127 (Latest) for dimensions and packing, and product performance indicators such as Maximum OSPL 90 and HF Average OSPL 90. Ensure telecoil sensitivity and multi-channel capability meet listed specifications.

Delivery terms allow extension based on the option clause; original delivery period applies, with an additional time formula to cover increased quantity: (Increased quantity ÷ Original quantity) × Original period, minimum 30 days. Adjustments apply if quantity changes within the contract.

Bids may offer an optional comprehensive warranty; if selected, this warranty supersedes the standard catalogue warranty. Ensure warranty terms align with MDR requirements and IS 16127 packaging while providing service support and replacements as needed.

Submit a valid Medical License for the product issued by the competent authority under the Drugs and Cosmetic Act 1940, along with any renewal certificates. Licensing demonstrates compliance with government medical device regulations and supports eligibility in the Indian Army bid.

Provide evidence of MDR 2017 compliance, dimension and packing conformance per IS 16127, device programming capabilities, microphone and AGC features, and telecoil specifications. Include minimum channel count, frequency range, and low battery indicator details for bid evaluation.

Key parameters include Maximum OSPL 90, HF Average OSPL 90, HF Average Full on Gain at 50/60 dB, and Minimum Number of Channels/Bands, plus Induction Coil/Telecoil sensitivity and low battery indicator; ensure all meet listed ranges and IS 16127 compatibility.