Why Used CE-Marked Medical Equipment Can’t Simply Be Imported into Ukraine

A practical guide for importers, clinics and distributors

A typical situation

Importers and clinic owners regularly come to me with roughly the same request:

“We have used equipment with a valid CE mark. It worked fine in a European clinic. Why can’t we just bring it into Ukraine and use it?”

The question sounds logical. There is a CE mark. The equipment works. The price is attractive. So what is the problem?

The problem is not the CE mark. The problem is the business model of the used medical equipment market.

Why used equipment is cheap — and what is behind it

A low price on used medical devices is rarely a coincidence. In the vast majority of cases — in my experience, about 90% of requests — the equipment is cheap precisely because the manufacturer no longer supports it from a regulatory point of view.

What this means in practice:

The technical documentation is outdated or unavailable. The manufacturer has updated the product line, the model is discontinued, and it is not obliged to provide a current technical file for the old device — and most often it won’t.

The Notified Body certificate has expired or been withdrawn. The CE mark is valid only as long as the relevant NB certificate is valid (for Classes IIa, IIb, III). If the certificate has not been renewed, the CE mark is in effect no longer valid, even if it is physically on the device.

The manufacturer does not cooperate on conformity assessment. Registration in Ukraine requires a set of documents from the manufacturer. If the manufacturer refuses or simply does not reply, the process stops.

So when an importer sees a “good price” on used equipment, they are actually buying a device that no longer exists from a regulatory point of view. Physically — yes. Legally — it is a problem.

How this is regulated in Ukraine

Ukrainian medical device legislation makes no exceptions for used equipment. Under Technical Regulations No. 753 and No. 754, any medical device placed on the Ukrainian market for the first time must be registered — regardless of:

• whether it has a CE mark
• the device’s history of use
• the reason it is being moved (commercial sale, non-commercial transfer, clinic relocation, etc.)

This means: if the equipment has never been registered in Ukraine before, it has to be registered from scratch. The procedure and documents are the same as for new equipment.

For CE-marked devices there is a simpler route — the CE recognition pathway. It really is simpler than a full conformity assessment. But it still requires up-to-date documentation from the manufacturer. If the manufacturer does not provide it, the simpler route closes, and what remains is either a full conformity assessment or giving up on the import.

Comparison: how other markets handle this

The situation in Ukraine is not unique. Most regulated markets take a similar approach.

European Union

Within the EU, used medical equipment does not need re-certification when it moves between clinics or changes owner. This is because of the “placing on the market” concept: if a device has already been placed on the EU market, it is already “on the market”, and it is not placed on the market again.

But it is important to understand that this rule applies only inside the EU. Exporting used medical equipment outside the EU — to third-country markets — requires compliance with the importing country’s requirements. And almost everywhere this means registration.

That is why many European dealers of used medical equipment sell only within the EU: legally exporting the goods to outside markets is extremely difficult.

China

China is even stricter. The NMPA (National Medical Products Administration) does not accept the CE mark as grounds for simplified registration — every device is registered under Chinese requirements, whether or not it has a CE mark. For used equipment it is even harder: China officially restricts or fully bans the import of used medical equipment in many categories. Registration of new equipment takes 1 to 3 years, depending on the class. For used equipment, in most cases it is simply a ban.

USA, Japan, Brazil

Each of these markets has its own medical device registration system:

• USA — FDA 510(k) or PMA, depending on the class
• Japan — PMDA, its own conformity assessment procedure
• Brazil — ANVISA, registration is mandatory

In none of these countries does the CE mark exempt a device from local registration. And in none of them is “used” status grounds for a simpler procedure.

The logic of the system: why it works this way

This is not bureaucracy for the sake of bureaucracy. There is a clear safety logic behind the registration requirement.

The manufacturer is responsible for the safety of a medical device throughout its whole life cycle. That means an up-to-date technical file, post-market surveillance, and being ready to give documentation to the regulator at any time.

Used equipment is a device with an unknown or incomplete history: unknown actual wear, unknown storage and transport conditions, possible unofficial modifications or repairs. The regulator cannot control the safety of such a device without a current file from the manufacturer.

So the global regulatory system in effect pushes the market toward new equipment. Not as protectionism, but as a way to keep patients safe.

Practical takeaway

If you are thinking about importing used medical equipment into Ukraine, first find out:

• Does the manufacturer still support this equipment from a regulatory point of view? Is it ready to provide current technical documentation?
• Is the Notified Body certificate valid (for Class IIa and above)?
• Is this equipment registered in Ukraine under any applicant? If so, there may be a simpler route through authorized importer status.

If the answer to the first two questions is “no” or “we don’t know”, legal import of the equipment will most likely be either very expensive or impossible. And then the “good price” turns into extra costs or a blocked project.

At RAA we regularly get requests like this and help clients assess the real route before they decide to buy. If you have a specific question, get in touch.

Serhii Kharchenko
Regulatory Affairs Agency | ukraine-raa.com