Great news! VitaiMed Instrument Co., Ltd. has successfully completed its FDA medical device Facility Registration. The facility information and over one hundred medical device products of the company have been officially entered into the US FDA regulatory database, marking critical progress in the company’s compliance roll‑out for the North‑American market.
FDA facility registration and product listing constitute the fundamental compliance requirements for overseas medical devices intended for trade in the US market. Enterprises must submit complete information including facility entity details, product classification codes, product generic names, manufacturing roles and other full‑set data. Only upon completion of official system filing and registration can products be cleared for import into the United States.
The scope of this listing covers VitaiMed’s core product lines, including full‑range ostomy products, urinary drainage care, skin & wound care, medical dressings, single‑use care consumables, operating‑room care accessories, post‑partum care, waste‑liquid collection products and multiple other categories. More than one‑hundred products are included, such as ostomy bags, ostomy care accessories, urinary drainage bags, ostomy baseplates, skin protective films, adhesive removers, various wound dressings, ostomy irrigation kits and abdominal support belts. It fully demonstrates the company’s comprehensive product portfolio within the care‑consumable sector.
From document sorting and product classification matching, coordination with the US Agent, to online submission, the regulatory team worked in close collaboration with business departments. In strict compliance with US regulation 21 CFR Part 807, every product code, product denomination and manufacturing‑entity record was cross‑checked. After multiple rounds of verification and refinement, the FDA system filing was successfully accomplished and the official Owner/Operator Number was obtained.
With this FDA filing credential, complemented by existing international certifications such as ISO 13485 and CE‑MDR, VitaiMed’s global compliance framework has been further strengthened. This achievement serves as a comprehensive validation of the company’s internal quality management and documentation‑compliance capabilities, and forms an essential cornerstone for developing North‑American markets and engaging US importers and healthcare‑institution channels.
Looking ahead, VitaiMed will continue to benchmark against medical‑device regulations worldwide and further improve its product‑compliance system. Guided by real‑world clinical patient needs, the company will keep developing safe and reliable care consumables, expand its global business footprint, and deliver high‑quality Chinese‑manufactured care solutions to more overseas medical institutions and end‑users.
Name: Catherine
Phone: +86 215 8399 546
Mobile: +86 139 1863 8349
Email: [email protected]
WhatsApp: +86 139 1863 8349
