EU Authorized Representative for Taiwanese Medical Device and Component Manufacturers
Taiwan exports into Europe mostly as a supplier rather than as a brand: OEM and ODM production, electronic subassemblies, optical modules and monitoring equipment. That makes the ownership question — who is the legal manufacturer under the MDR — more decisive for Taiwanese companies than the classification question that dominates most country guides. A TFDA licence under the Medical Devices Act does not settle it, and neither does a supply contract that never mentions the Regulation. This page works outwards from that contract.
Start with the contract, not with the regulation
Most Taiwanese device companies reach Europe through someone else's brand. OEM and ODM work is the backbone of the island's device sector, and it means the first MDR question is not classification or testing but ownership: when the product reaches a hospital in Lyon or Lisbon, whose name is on the label?
The Regulation answers by definition. A manufacturer is the person who manufactures a device or has it designed and manufactured, and markets it under its own name or trademark. Building the device does not make you the manufacturer. Putting your name on it does. Everything else on this page follows from where that line falls in your particular arrangement.
| Your arrangement | Who is the MDR manufacturer | What your Taiwanese company needs |
|---|---|---|
| Pure OEM: European customer's brand only on the device | The European customer | No authorised representative. A supplier agreement and design-record access for the customer's technical file |
| ODM: you design it, the customer brands it | The European customer, provided it is identified on the label and accepts manufacturer obligations | Nothing under Article 11, but you own the design evidence the customer's notified body will ask for |
| Your brand appears on the device, packaging or IFU | Your Taiwanese company | A sole EU Authorized Representative, the technical documentation, the declaration of conformity, an SRN |
| Sold under your brand through a European distributor | Your Taiwanese company; the distributor is a distributor | Article 11 mandate, plus a named importer registered in EUDAMED |
| Distributor relabels under its own brand | The distributor, unless the agreement keeps you named on the label | A written agreement recording who carries which obligation |
What a TFDA licence covers, and what it stops at
Taiwan has regulated devices under its own Medical Devices Act since 2021, separately from the pharmaceutical framework it previously shared. Devices are classified in three classes under the Regulations Governing the Classification of Medical Devices. Class 2 and Class 3 devices go through registration and market approval to obtain a medical device licence; Class 1 items are handled through listing and annual declaration under the Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration.
On the quality side, Article 22 of the Medical Devices Act requires manufacturers to establish a quality management system complying with the Medical Device Quality Management System Regulations, and manufacture may only begin after a compliance inspection by the central competent authority and issue of a manufacturing licence. That licence runs for three years and is renewed in three-year extensions.
None of it produces anything a notified body can use. A TFDA licence is a domestic marketing permission and a domestic QMS attestation. The Union recognises neither. What the licence does prove internally is that your plant has already survived a regulator's on-site inspection, which is a materially different starting point from a manufacturer that has only ever been audited by a certification body.
TFDA sits at the MDSAP table as an affiliate, not a member
This distinction is worth getting right because it is often reported loosely. The MDSAP participating members are the regulators of Australia, Brazil, Canada, Japan and the United States. TFDA is listed as an MDSAP affiliate member, alongside regulators such as those of Argentina, Israel, Kenya, Korea, Mexico and South Africa. The European Union is an Official Observer.
The practical consequence for a Taiwanese manufacturer is simple. Even if you commission an MDSAP audit to serve customers in Japan or the United States, that audit satisfies no MDR obligation, and it does not satisfy a TFDA obligation either. The Annex IX quality management system assessment is separate, is conducted by a notified body designated for your device codes, and brings the unannounced audits required at least once every five years under Annex IX Section 3.4.
Components, subassemblies and the reach of Article 23
Taiwan's device sector grew out of its electronics industry, and a large share of what leaves the island is not a finished device at all: sensors, optical modules, power supplies, cable assemblies, PCBs, housings and display subassemblies destined for someone else's system. Component supply is usually outside the MDR, because a component is not placed on the market as a device.
Article 23 is where that stops being automatic. Its second paragraph is explicit: "An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation." Sell a spare part into the European aftermarket that changes what the host device does, and you have placed a device on the market with everything that follows. Sell a like-for-like replacement and Article 23(1) instead requires you to ensure it does not adversely affect safety and performance, and to keep the supporting evidence available for competent authorities.
Patient monitors and the 'immediate danger' clause in Rule 10
Monitoring equipment is one of the categories Taiwan does export under its own brands, and it sits on a rule with an unusually sharp edge. Active devices for diagnosis and monitoring are class IIa when they allow direct diagnosis or monitoring of vital physiological processes "unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system" (MDR Annex VIII, Rule 10), in which case they are class IIb.
Two products that look identical on a bench can therefore end up a class apart purely on how their intended purpose is written. A pulse oximeter positioned for wellness spot-checks and one positioned for continuous monitoring of a deteriorating patient are not the same regulatory object. Software inside the monitor may go higher again: Rule 11 puts software that informs diagnostic or therapeutic decisions in class IIa as a floor, rising with the severity of the harm a wrong decision could cause.
Who signs the mandate, and who signs the declaration
If your own brand goes to Europe, Article 11(1) allows the device on the Union market only where you designate a sole authorised representative. The designation is the mandate, and it is valid only when accepted in writing, effective at least for all devices of the same generic device group. Article 11(3) sets the minimum tasks; Article 11(4) prevents delegation of the core manufacturer duties in Article 10; Article 11(5) makes the representative jointly and severally liable for defective devices where a non-EU manufacturer has not complied with Article 10.
The declaration of conformity stays yours. So does the technical documentation, the risk management file, the clinical evaluation and the post-market surveillance system. What we hold is the copy, the mandate, the registrations and the obligation to answer a competent authority in its own official language. We do that from Ankara, İstanbul and Gdańsk, with an in-house PRRC who is a partner of the firm and has a deputy. The mechanics are set out on our EU Authorized Representative page, and the actor and device entries on our EUDAMED registration page.
What Taiwanese plants ask when a European customer changes the deal
Our customer now wants our brand on the product. What changes?
Everything. You become the manufacturer under the MDR, which means the technical documentation, the declaration of conformity, the conformity assessment route, the PRRC, the post-market surveillance system and the Article 11 mandate all become yours. Price that shift before you agree to it, not after. Our fees are published and class-based, from EUR 1000 a year, so the cost side is at least easy to model.
We supply subassemblies only. Are we really outside the MDR?
Usually yes, while the item is supplied into another manufacturer's production and not placed on the market as a device or as a replacement part. Check Article 23 against your aftermarket sales, because spare-part supply is where component makers cross the line without noticing.
Does our TFDA manufacturing licence reduce the notified body audit?
No. It is not recognised in the Union and TFDA's MDSAP affiliate status does not change that. It does mean your site has been inspected by a regulator, so the gap is normally evidence structure rather than shop-floor practice: GSPR mapping, clinical evaluation and PMS documentation rather than production control.
We also sell into Türkiye. Is that covered by the same mandate?
No. Türkiye is a separate market access route with its own registration requirements, handled separately from Article 11 representation. See Türkiye market access if that is on your roadmap.