EU/UK Authorised Representatives: finding Chinese manufacturers that need you

Why now

Under EU MDR/IVDR, non-EU manufacturers must appoint an Authorised Representative established in the EU; for Great Britain, the equivalent is a UK Responsible Person (UKRP). With EUDAMED Actor registration now required and the transition deadlines behind us, the pool of Chinese manufacturers that still need EU representation is large - and it is continuously refreshed by new NMPA filings.

Chinese manufacturers rarely announce their export plans. What they do publish is domestic registration activity - and that activity is the leading indicator.

How to read the NMPA signal

• Fresh filings = active pipeline. A spike in NMPA registrations means the company is commercializing products now - the same products it will later need to place in the EU/UK.
• Category matters. This week's evidence-passed pool is heavily consumables (27 of 36) - devices that fit Class I/IIa MDR routes where an AR and a notified body are both needed.
• Cross-market evidence. A company that already holds an FDA establishment registration (12 of 36 this week) is export-oriented and familiar with foreign compliance - a prime EU AR prospect.

What to say

Open with the specific registration activity, then connect it to their EU obligation:

"I saw [company] registered [N] new device(s) with NMPA on [date]. When you export to the EU, MDR requires an Authorised Representative in the EU (and a UKRP for Great Britain) before you can place devices on the market. We handle that role and would be glad to review your product scope - no obligation."

One targeted message beats a hundred generic ones, and the registration reference proves you did your homework.