Antiseptics and general medical consumables — single-use syringes and needles, IV administration sets, examination gloves, dressings and umbilical-cord care gel — supplied against an ISO 13485 quality route with full export documentation.
Consumables follow a different regulatory route from medicines, and procurement documents that treat them the same way run into trouble at the border. Where WHO guidance does apply, it is specific: chlorhexidine digluconate for umbilical cord care, and single-use or safety-engineered injection equipment.
No. Devices generally follow a different route — typically ISO 13485 as the quality system, with CE marking or national device registration depending on the market. Tell us the destination and we confirm the documents the authority expects.
Yes. Cord-care chlorhexidine digluconate gel and solution are supplied at the concentration used in the WHO recommendation, with the labelling separated clearly from ophthalmic products.
Single-use syringes, needles and IV administration sets are supplied sterile, with sterilisation validation and batch release documentation.
Every line is quoted against a written specification: monograph, strength, pack configuration, release tests and the documents that ship with the batch. Certificates of analysis, stability data and the GMP certificate accompany each consignment; dossier and registration support are provided where the market requires a filing.
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Reference information only. Published guidance is quoted for professional and regulatory-context purposes and is not medical advice or a prescribing recommendation.
