Sourcing medical devices and PPE from China

Two regimes that get confused constantly

Medical devices and personal protective equipment are different things under UK law, with different regulators, different routes to market and different obligations. They get treated as one category because a single product, a face mask being the obvious example, can be either depending on its intended purpose and the claims made for it.

Getting this wrong at the start is expensive, because the two routes diverge early and you cannot retrofit one onto the other. So the first question is not which factory, it is which regime does this product sit in, on the basis of what I intend to claim for it.

If it is a medical device

A manufacturer outside the UK must appoint a UK Responsible Person, and the device must be registered with the MHRA before it is placed on the Great Britain market. Both apply regardless of class, including Class I. What class changes is the conformity assessment route and whether an approved body has to be involved.

Those steps take time and cannot be compressed to fit a launch date, which is the single most common planning failure in this category.

CE marked devices are still accepted for Great Britain on a transitional timetable rather than being shut out, so a CE marked device is not automatically a problem. The dates depend on which EU regime the device was certified under, so confirm the position for your specific device before you either reject CE marked stock or assume it has years left.

If you sell under your own name or trade mark, you are normally treated as the manufacturer rather than the importer, which means the technical documentation, the declaration of conformity and the obligations behind the marking are yours. Establish who holds which role, in writing, before ordering.

If it is PPE

There is no MHRA registration and no UK Responsible Person requirement in the medical device sense. PPE is UKCA or CE marked under the PPE rules, and the category determines the route: simple risks can be self-declared, while Category II and Category III require an approved body, with ongoing surveillance for Category III.

So the practical questions are what category the product falls into, whether an approved body was genuinely involved, and whether the certificate and declaration cover your exact configuration and can be issued naming your company.

Buyers importing protective gloves, eyewear, masks and workwear are frequently told by suppliers that a product is certified without any statement of which category or which body. That is not evidence.

Verifying evidence in a category where forgery is common

This is a sector with a well-documented history of fabricated certificates, particularly around masks and protective equipment. Treat a PDF as a claim rather than as proof.

Verify with the issuing body directly, using the body's own identifying number and contact details rather than the ones on the certificate. Check the scope covers your exact product configuration and materials, check the dates, and check whose name it is in.

Ask for the underlying test reports rather than just the certificate, and ask who holds them. A supplier who can only produce a summary certificate for a third company is not a supplier you can build a compliance file on.

Quality points that matter more here than elsewhere

Traceability is not optional. Batch coding, records that link a finished unit to a material batch, and retained samples are what turn a problem into a targeted withdrawal instead of an open-ended one.

Specify materials precisely, and require approval for any substitution, because in this category a substituted material is a compliance change and not just a quality change. Specify sterile status and method where relevant, shelf life and storage conditions, and packaging integrity.

Require testing on production units rather than accepting only type-test evidence from an earlier build.

Planning the order properly

Decide the intended purpose and the claims first, because they decide the regime. Then establish the route: class or category, and whether an approved body is required.

Put the standards, the required evidence, whose name it must be in and the exact configuration into the specification before asking for a price. Appoint any UK Responsible Person and complete registration before goods arrive, not after.

Then order, inspect on production units, verify markings and instructions, and keep the documentation available for the periods required. This is a category where the paperwork is genuinely part of the product.