What certifications should an acne patch factory have?

Short answer: ISO 13485 covers how the factory is run and which product categories are in scope. FDA registration covers the facility and the product listing for the US market. CE marking for an acne patch is a Class I self-declaration, not a certificate issued by a notified body. They are three separate things, and a supplier who describes any one of them as "all the certification you need" is telling you something useful about how they work.

ISO 13485 — the scope statement matters more than the certificate

ISO 13485:2016 certifies that the factory has documented processes for design control, supplier management, traceability, non-conforming product handling and corrective action. It does not certify any individual batch — a certified factory can still produce a failed lot. What the certificate gives a buyer is confidence that failures get caught and traced rather than shipped silently.

The part buyers should actually read is the scope statement, which lists the product categories covered. A certificate scoped only to wound dressings does not automatically cover cosmetic patches, and that distinction surfaces at customs. Ask for the scope page, not just the cover.

CE — Class I means self-declaration, and the wording matters

An acne patch is classified as a Class I medical device. Under the MDD Annex VII route, Class I devices do not require a notified body certificate — the manufacturer declares conformity themselves, and a compliance report from a third party reviews the technical file and test reports that support that declaration.

This is why the document is a compliance report rather than a certificate. The report itself states: "This report is not a certificate of conformity." A supplier who calls it a CE certificate is either misreading their own paperwork or hoping you will.

FDA — two registrations, routinely conflated

For the US market there are two distinct steps, and suppliers usually mention only the first:

• Establishment registration — the facility is registered with FDA and assigned a Facility Establishment Identifier (FEI). This concerns the building, not the product.
• Device listing — each product is listed under that registration, with its classification.

"We are FDA registered" normally means the first. Necessary, but not sufficient: if the product is not listed, a shipment can still be held. Ask for the FEI number and the listing confirmation as two separate items.

What each one proves

One question worth asking in 2026

The EU Medical Device Regulation (2017/745) replaced the MDD in May 2021. A Class I device still self-declares under MDR, but the technical documentation has to meet MDR Annex II and III rather than the older MDD annexes.

So when you receive a compliance report citing 93/42/EEC, ask whether the technical file has been updated to MDR. For Class I devices this is usually a documentation exercise rather than a re-certification, but it is the difference between a smooth EU customs entry and a hold. Suppliers whose paperwork stops at MDD are not necessarily non-compliant — they may simply not have been asked.

The document set to request before a first order

• ISO 13485 certificate including the scope page, with expiry date
• CE declaration of conformity naming the regulation, plus the supporting compliance report
• FDA FEI number and the product listing confirmation, separately
• Material safety data sheet for the adhesive and the film
• A batch certificate of analysis from a recent production run
• Stability or shelf-life statement, with test conditions

Any of these that a supplier cannot produce within a few days is a signal worth weighing before you place a tooling order.