Do I need a GPSR technical file if I manufacture in China?
Yes, without exception. The GPSR is triggered by where the product is sold to consumers, not where it is manufactured. A factory in Guangdong, a trading company in Shenzhen, or a brand owner in Shanghai who sells any non-food product to a consumer in France, Germany, the Netherlands, or any other EU Member State must comply with Regulation (EU) 2023/988 in full. This includes having a technical file for each product type, prepared according to the requirements of Article 9, and designating an EU-based Responsible Person under Article 16 before the first sale to any EU consumer.
One of the most persistent misconceptions among China-based sellers is that Chinese laboratory certifications, factory audit reports, or ISO quality certificates substitute for the GPSR technical file. They do not. Chinese testing reports from CNAS-accredited laboratories or international laboratories may be valuable supporting documents within the technical file, but the GPSR technical file is a distinct document that must: contain an internal risk analysis conducted according to EU safety criteria, referencing applicable European EN standards; include a Declaration of Conformity citing Regulation (EU) 2023/988 and any other applicable EU legislation by name; and provide safety instructions and warnings drafted in the official language or languages of each country where the product is sold. A technical file drafted entirely in Chinese and referencing only GB standards does not meet the GPSR requirement.
For Chinese manufacturers or Amazon FBA sellers sourcing from China, the EU Responsible Person designation is the most urgent practical step. EU customs authorities have been actively checking for Responsible Person information on shipments from China since December 2024. A shipment that cannot demonstrate an EU contact point can be held at the border, with the importer bearing the storage and release costs. On Amazon, sellers from outside the EU who do not provide valid Responsible Person details in Seller Central have their EU listings deactivated. The Responsible Person must have a physical address within an EU Member State — a PO box or virtual office is generally insufficient for legal compliance purposes.
What the law says
Article 9.1 of Regulation (EU) 2023/988 requires manufacturers to carry out a risk assessment and compile technical documentation — regardless of where they are based. Article 16.1 requires an EU-established Responsible Person to be in place before any product is placed on the EU market. Both obligations apply fully to Chinese manufacturers.
Consequences of non-compliance
Customs blockage at EU borders — goods can be held, inspected, and destroyed. Listing deactivation on all EU Amazon marketplaces. Fines of up to €100,000 per Member State, applied against whoever is reachable within EU jurisdiction — typically the importer. Civil liability for product-related harm under the EU Product Liability Directive.
Whether you manufacture in China or source from Chinese suppliers, GPSRCheck generates the GPSR-compliant technical file in minutes — risk assessment, EU Declaration of Conformity, EN standards, labelling checklist. €49.
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