Manufacturers in China need an EU Authorised Representative to place devices on the EU market — NMPA registration doesn't carry over. Axiom Biotek acts as your AR from Sweden, under a documented quality system with a qualified PRRC, and reviews your technical documentation before we put our name on your label.
A Chinese registration certificate and a CE mark are separate approvals. To place a device on the EU market you need to meet MDR or IVDR requirements and — because you have no registered place of business in the EU — designate an Authorised Representative by written mandate.
Much of what you already have is reusable: an ISO 13485 quality system, risk management, test reports and design files. Our job is to map it onto MDR/IVDR technical documentation, show you where the gaps are, and help close them.
We read your technical documentation against MDR/IVDR before we sign a mandate, and tell you plainly what's missing.
A single person who has read your file — for you, and for competent authorities and notified bodies when they ask.
The gaps we find are gaps we can help you close — regulatory strategy, technical documentation and QMS support from the same team.
Yes. China is a third country under MDR/IVDR, so a manufacturer without a registered place of business in the EU must designate a sole Authorised Representative, by written mandate, before placing devices on the EU market.
No. NMPA registration governs the Chinese market; CE marking under MDR/IVDR governs the EU market. Holding one doesn't grant the other, although an existing ISO 13485 system and technical files can be mapped across rather than rebuilt.
Yes. A device made outside the EU is placed on the market through an importer, which has its own obligations under Article 13 — separate from the AR's under Article 11. We can help you work out who covers what.
An Authorised Representative is legally liable for defective devices jointly and severally with the manufacturer. That's why we review your documentation before accepting a mandate, rather than simply lending our name.
Tell us where your technical documentation stands today — we'll tell you honestly what an Article 11 mandate with us would look like.
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