Meaning
Comprehensive collections of engineering files and compliance evidence prove that an electronic product meets all relevant regulatory standards. Preparing a technical documentation dossier is required before applying for equipment certification in international markets. This collection is limited to design specifications and compliance certificates and does not include marketing or sales plans.
The file must be maintained by the manufacturer for several years after production ends to ensure that any post-market inquiries can be answered with verifiable data.
Design Schematics
Engineering diagrams must reveal the physical and electrical structure of the device. Inside the technical documentation dossier, schematics and board layouts are included to show the placement of RF components. These drawings are kept confidential to protect the proprietary technology.
Compliance Proof
Test reports from accredited laboratories form the core of the file. The technical documentation dossier compiles the measurements of emissions, immunity, and safety to demonstrate that the hardware meets the required limits. This compiled proof is inspected during audits.
Agency Access
National authorities can demand to inspect these documents during market surveillance. A technical documentation dossier must be provided to the agency within the specified number of business days. This capability is required to maintain the validity of the sales license.
