EU Authorized Representative for Hong Kong: From MDACS Listing and the LRP to MDR Article 11

MDACS is an administrative, voluntary scheme

The Medical Device Division describes the origin of the system in its guidance notes GN-01. The scheme was introduced pending legislation, with a listing system under which manufacturers and importers of medical devices "(except Class I devices) could VOLUNTARILY list their products with the Department of Health" (GN-01, Clause 1.1.1). The same guidance explains that the system and the planned statutory control are based largely on the recommendations of the International Medical Device Regulators Forum.

The European position is the opposite in both respects. The MDR is a regulation with direct legal effect in every Member State, and compliance is a condition of placing a device on the market, not an option:

"A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose." (MDR Article 5(1))

A Hong Kong manufacturer that has never listed its devices with the Medical Device Division is not at a disadvantage in Europe, and one that holds listings is not ahead. The EU conformity assessment starts from the MDR itself.

Classes I to IV under MDACS and classes I to III under the MDR

GN-01 states that MDACS classifies general medical devices into four classes, I to IV, according to Technical Reference TR-003, with class IV the highest risk, and in vitro diagnostic devices into classes A to D under TR-006 (GN-01, Clauses 3.3.1 and 3.3.2). The MDR uses three class labels with a split in the middle:

"Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII." (MDR Article 51(1))

The number of classes is the same, but the rules are not. Annex VIII contains twenty-two rules, including specific rules for software, nanomaterials and substances absorbed by the body. A device listed as class II in Hong Kong should be classified again under Annex VIII rather than mapped by label. In vitro diagnostic devices go to Regulation (EU) 2017/746, which also uses classes A to D, again with its own rules.

The Local Responsible Person and the EU authorised representative

The two roles look alike on paper. Both exist because the manufacturer may be abroad, both handle complaints and adverse events, and both are the regulator's point of contact. GN-01 sets the eligibility of the Local Responsible Person:

"it is EITHER a legal person incorporated in Hong Kong, OR a natural or legal person with business registration in Hong Kong" (GN-01, Clause 4.3.1(a))

The EU requirement is defined by establishment in the Union:

"‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;" (MDR Article 2(32))

A Hong Kong LRP cannot hold an EU mandate, and an EU authorised representative cannot act as LRP. Manufacturers selling in both markets need both appointments. Under the EU–Türkiye Customs Union arrangement, the EU-side appointment may be a representative established in Türkiye.

Manufacturer for MDR purposes when production is in the Pearl River Delta

Many Hong Kong companies design and sell devices from Hong Kong while production takes place in mainland China. The MDR looks at the name on the product, not the location of the factory:

"‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;" (MDR Article 2(30))

Where the Hong Kong company markets the device under its own name or trade mark, it is the manufacturer, and because it is not established in a Member State it must designate a sole authorised representative under Article 11(1). Where a European brand owner places its own name on the device, that brand owner is the manufacturer, and the Hong Kong company becomes a supplier under the brand owner's quality agreement. Our page on China covers manufacturers registered in the mainland.

Getting the Union side in place from Hong Kong

Medex Kurumsal Danışmanlık is established in Türkiye. The European Commission's Notice to Stakeholders of March 2022 states that manufacturers established outside the territory of the EU or Turkey "only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey." Switzerland, Great Britain and the EEA-EFTA states require their own local representatives; Medex does not act for those markets.

The steps on our side:

1. Written mandate under Article 11(3). It records the minimum tasks, including verifying that the declaration of conformity and technical documentation exist and keeping copies available to competent authorities.

2. EUDAMED actor registration. Your company registers as manufacturer and receives its Single Registration Number, linked to our authorised representative SRN TR-AR-000057550.

3. UDI. Basic UDI-DI and UDI-DI data are registered for each device before it is placed on the market.

4. Person responsible for regulatory compliance. Medex's PRRC is in-house, as the Regulation requires:

"Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union." (MDR Article 15(6))

5. Label and IFU address. Annex I, Section 23.2(d) requires our name and registered address on the label of a device whose manufacturer is established outside the Union. Language requirements are set by each Member State under Article 10(11).

Medex works from Ankara, İstanbul and Gdańsk. We do not write technical documentation, we are not a notified body, and we do not find distributors. Annual fees are published on our pricing page, from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative.

Related country and guidance pages

Manufacturers in neighbouring markets face similar questions; we keep separate pages for China, Taiwan and Singapore. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.

Frequently asked questions

Our device is listed under MDACS. Does that help with CE marking?

Not as an authorisation. An MDACS listing has no standing in the Union. The evidence behind it, such as test reports, risk management files and clinical data, can be reused in MDR technical documentation if it was produced to recognised standards and is available in full.

Our device is class I and cannot be listed in Hong Kong. Do we still need an EU authorised representative?

Yes. Article 11(1) applies to every device whose manufacturer is not established in a Member State, whatever the class. Class I is the case where the authorised representative is often the only EU-side appointment the Regulation requires.

Can our Local Responsible Person in Hong Kong also be our EU authorised representative?

No. An authorised representative must be established within the Union under Article 2(32), or in Türkiye under the Customs Union arrangement. A Hong Kong entity does not meet that condition.

Does a Türkiye-based representative cover the whole EU?

Yes. The Commission's March 2022 notice confirms that manufacturers outside the EU and Turkey need only one authorised representative, either in the EU or in Turkey, to place devices on the market in the EU. Switzerland, Great Britain and the EEA-EFTA states require their own local representatives.

Sources

Department of Health, Medical Device Division — Guidance Notes GN-01: Overview of the Medical Device Administrative Control System — www.mdd.gov.hk

Department of Health, Medical Device Division — Medical Device Administrative Control System — www.mdd.gov.hk

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

European Commission — Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Related guides

Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.

Other countries we cover

We act as EU authorized representative for manufacturers in many markets. See the pages for Taiwan, Japan, South Korea, Singapore, the United States and China, or browse the full list by country and the list by device category.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.