What Certifications Do Medical Patches Need for Export: A Practical Walk-Through

For a health patch, the certification set is a stack, not a single certificate. The set is also jurisdiction-specific, so a brand owner exporting to both the EU and the US maintains two parallel sets. The two sets are not interchangeable. The article below walks through the typical stack a brand owner should expect to hold for a class II transdermal patch, by jurisdiction.

Scope note. Certification route depends on the classification of the product in each jurisdiction. A wellness patch marketed as a cosmetic is a different stack. The sets below assume a transdermal or therapeutic claim and a class II classification in both jurisdictions.

European Union stack

The base layer is a notified-body CE certificate. The class IIa route under Regulation (EU) 2017/745 Annex VIII is the most common route for a transdermal pain patch. The notified body audits the technical file and the quality system; the certificate is renewed on a five-year cycle for class IIa.

Stacked on top of the CE certificate:

• Declaration of Conformity (DoC) issued by the manufacturer, drawing together the technical file, the CE certificate, the UDI assignment, and the post-market surveillance plan.
• EUDAMED registration for the manufacturer, the device, and the UDI. UDI is mandatory for class IIa and above.
• Person Responsible for Regulatory Compliance (PRRC) appointed by the manufacturer and named in the technical file.
• ISO 13485:2016 certificate from an EU-accredited certification body, even though it is not a CE mark, since it is required as supporting evidence in the technical file.
• REACH compliance dossier for any substance in the device or its packaging. The dossier is held by the manufacturer and is available on request to the regulator.

United States stack

The base layer is an FDA Establishment Registration. This is the owner/operator registration of the brand owner, not the product itself. It is renewed annually between October and December.

Stacked on top:

• FDA Device Listing for the specific product, listing the product code, the device class, and the regulatory submission type.
• FDA 510(k) Premarket Notification for class II products, with a clearance letter from FDA showing substantial equivalence to a predicate device. The 510(k) is held by the brand owner and the contract manufacturer is named on the letter.
• QMSR compliance as of 2 February 2026, the Quality System Regulation has been replaced by the Quality Management System Regulation, which incorporates ISO 13485:2016 by reference. The brand owner must hold evidence of QMSR-grade quality management.
• Unique Device Identification (UDI) issued through an FDA-accredited Issuing Agency, with the device identifier and production identifier recorded in the Global Unique Device Identification Database (GUDID).

Country-of-origin layer (for buyers in regulated markets)

For buyers in EU member states and US states, the manufacturer in China additionally maintains:

• China NMPA (formerly CFDA) registration if the product is also marketed in China. NMPA does not accept 510(k) clearances in lieu.
• China Customs Export License for the active ingredient, depending on the category under the Customs commodity code.

How the stacks interact with the brand owner

The brand owner holds the regulatory file, but the OEM factory holds the underlying evidence: batch records, validation data, stability data, complaint records. The two sets of records must agree at every audit. A factory that does not allow the brand owner to see the underlying records is a liability, regardless of the certificates it shows.

Henan Hanmeng Bio-Tech supports class II transdermal projects with documentation aligned to both stacks. The brand owner remains the regulatory file holder and the EUDAMED/FDA registrant.

Sources

• Regulation (EU) 2017/745 on medical devices (MDR), Annexes II, III, VIII, IX, X, XI.
• U.S. Code of Federal Regulations, Title 21, Parts 807, 820, 830.
• U.S. Food and Drug Administration, Medical Devices; Quality System Regulation Amendments (Federal Register, 2 February 2024, effective 2 February 2026).