Regulatory Compliance
This page sets out the regulatory position of Migibio products, the quality system behind them, and the documentation you can obtain for your market. It describes what is verifiable about our manufacturing and classification — nothing more. Where a market imposes its own registration requirements, we support your registration as a manufacturer, but the local approval itself rests with the importer or distributor in that country.
Manufacturer and Legal Entity
| Item | Detail |
|---|---|
| Legal name | Guangzhou Magic Biotech Co., Ltd. (广州敏捷生物技术有限公司) |
| Brand | Migibio |
| Registered address | G2-601, Najin Technology Industrial Park, No. 39 Ruihe Road, Huangpu District, Guangzhou City, Guangdong Province, China |
| Established | November 2017 |
| Business scope | R&D, production and sales of POCT veterinary diagnostic equipment and rapid test reagents |
| Products | Fluorescence immunochromatographic (FICT) analyzers and reagent kits for animal disease detection and health assessment |
Intended Use
Migibio products are intended for veterinary (animal) use only. They are not intended for human diagnosis, treatment, or screening, and must not be used on human samples.
- Intended operator — qualified veterinary professionals and veterinary laboratory personnel, following the product’s Instructions for Use (IFU).
- Sample types — serum or plasma (EDTA anticoagulant recommended) for most reagent kits; refer to the specific IFU for each analyte.
- Setting — veterinary clinics, animal hospitals and veterinary laboratories.
Regulatory Classification
Veterinary diagnostics are regulated differently from human in vitro diagnostics, and the difference is frequently misunderstood:
| Market | Position for veterinary-only IVDs |
|---|---|
| European Union | Outside the scope of the IVDR (2017/746), which applies to in vitro diagnostics for human use. There is no single unified EU framework for veterinary devices; requirements fragment across member states and may treat some reagents as veterinary medicinal products. |
| United States | Regulated through the FDA’s Center for Veterinary Medicine (CVM), a different pathway from the human 510(k)/PMA route. Requirements depend on the product and its intended use. |
| Other markets | Registration, import permits and local-authorised-representative requirements vary by country; some markets classify certain reagents as veterinary biologics or medicinal products. |
Because classification determines the entire registration pathway, we recommend confirming it before ordering. We have published a detailed importer’s map in Veterinary IVD Import Rules: CE, FDA and the Country Maze.
Quality Management and Manufacturing
- Quality management system — operated under an ISO 13485-certified quality management system (medical devices and in vitro diagnostics), alongside an ISO 9001-certified quality management system.
- Manufacturing — GMP-certified production principles across a 2,000 m² R&D and production workshop.
- Traceability — full lot traceability from incoming materials through production to the finished kit.
- Lot release — lot-release testing before shipment, with assay-specific validation documented in each reagent’s IFU.
- Platform performance — manufacturer-reported precision (CV% <10%) and pg/ml-level limit of detection; see Research & Analytical Performance for how platform-level figures differ from assay-specific clinical performance.
Certificates, certification scope and current validity are supplied on request to qualified buyers, and we encourage you to verify any certificate directly with the issuing body.
Documentation Available
| Document | Availability |
|---|---|
| Instructions for Use (IFU) | Printed copy with every kit; electronic copy on request |
| Certificate of analysis (lot release) | With the shipment or on request |
| Safety data sheet (MSDS) | On request |
| Commercial invoice, packing list | With every shipment |
| Certificate of origin | On request |
| Free-sale certificate | On request |
| ISO 13485 certificate (with scope) | On request — ask our team for the current certificate |
| Certification documents with scope | On request to qualified buyers |
| Validation report for a specific assay or analyzer | On request |
Support for Distributors and Registration
For OEM/ODM and private-label projects, regulatory responsibilities and required documentation are scoped per project and per target market. We provide manufacturer-side documents, labelling support and technical dossiers for your registration submission; the local registration, import authorisation and market surveillance obligations remain with the importer or distributor in the destination country. See OEM / ODM & Private Label for programme details.
Document Requests and Compliance Questions
For certificates, declarations, technical dossiers or compliance questionnaires, contact us with your company name, market and the specific product catalog numbers involved — see Contact Us. For product documentation, IFU and SOP templates, see Support & Downloads.
Last updated: 21 September 2026. This page describes our manufacturing and regulatory position; it is not legal advice, and importers should verify the requirements of their own market.
Frequently asked questions
- Do Migibio veterinary diagnostic products require CE marking?
- No. CE marking under the EU In Vitro Diagnostic Regulation (IVDR 2017/746) applies to in vitro diagnostics intended for human use. Migibio products are intended for veterinary (animal) use only and sit outside that framework. What a veterinary diagnostic requires instead depends on the destination market — the EU has no single unified veterinary-device framework, and requirements vary between member states.
- Who is the legal manufacturer of Migibio products?
- Guangzhou Magic Biotech Co., Ltd. (广州敏捷生物技术有限公司) of Guangzhou, China. Our registered address is G2-601, Najin Technology Industrial Park, No. 39 Ruihe Road, Huangpu District, Guangzhou City, Guangdong Province, China.
- Which quality certifications does Migibio hold?
- Migibio operates an ISO 13485-certified quality management system for medical devices and diagnostics, alongside ISO 9001-certified quality management and GMP-certified manufacturing. Certificates, together with their scope and validity, are supplied on request so that you can verify them directly with the issuing body.
- What documentation accompanies each order?
- Every shipment includes a commercial invoice, packing list and the product's Instructions for Use (IFU). Certificates of analysis (lot release), safety data sheets (MSDS), and documents such as certificates of origin or free-sale certificates are supplied with the shipment or on request.