Número da Revisão
Rev.00
Data de Expiração
15/04/2028
Descrição
Scope: "Design, development, import, export, distribution, sales and manufacture of Adhesive Tapes, Sterile absorbent wound dressing with or without antimicrobial agent, sterile and non-sterile adhesive absorbent wound dressing with or without antimicrobial agent, Compression and support bandages, Sterile and non-sterile hydrogel wound dressing with or without antimicrobial agent, amorphous gel with and without antimicrobial agent, Silicone gel for scars hyper-oxygenated fatty acid products, Hydro- active colloid paste, Sterile and non-sterile hydrocolloid wound dressing with or without antimicrobial agent, Sterile and non-sterile Cold sore & Acne patches, foot care plasters, Sterile foam wound dressing with or without antimicrobial agent, Sterile soft silicone polyurethane foam dressings with or without Antimicrobial agent, Lipocolloid dressings, Antimicrobial Lipocolloid dressings, Sterile non-adherent wound contact layer with or without antimicrobial agent, paraffin gauze dressings, antimicrobial paraffin gauze dressings, sterile saline wipes, alcohol swabs and alcohol free swabs, sterile alginate wound dressing with or without antimicrobial agent, with or without Carbon, Hydrofibers dressing with or without antimicrobial agent, sterile theatre incise drapes with or without antimicrobial agent, sterile skin closure strips, sterile catheter securement dressing with or without antimicrobial agent, Thermoregulating Pad, Bandages with Zinc Oxide paste, disposable protective clothing and face masks, the provision of ethylene oxide sterilization for single use medical devices as part of contact manufacturing”
Norma
ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Medical Devices Regulations – Part 1.1 – SOR 98/282 (as applicable) USA: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation
Status
Ativo