Receive expert guidance to navigate and achieve global compliance with confidence.
Contact our expertOver recent months, we have observed a growing trend in certain markets where regulators are shifting responsibility away from certification bodies onto manufacturers, importers and distributors through self-declaration schemes supported by stronger market surveillance and digital record-keeping requirements.
Unlike traditional pre-market certification, where products must be assessed before import and sale, these new frameworks place the responsibility on manufacturers to demonstrate ongoing compliance and maintain supporting technical documentation throughout the product lifecycle.
Similar to the European CE requirements, these schemes can accelerate market access and reduce administrative burdens. However, they also increase legal accountability and require more robust evidence to support compliance claims.
As responsibility shifts to manufacturers, the role of accredited laboratories and certification bodies becomes increasingly important, providing technical assurance that transforms self-declarations into credible, evidence-based claims. To avoid product recalls or legal action, manufacturers, importers and distributors are increasingly working with strategic partners like TÜV SÜD to ensure their self-declarations are accurate and compliant.
The specific compliance requirements are not necessarily changing – rather, it is how compliance is demonstrated and who carries the responsibility. Self-declaration is also increasingly becoming a digital declaration, with regulators relying on QR codes, online documentation hubs and market surveillance rather than traditional approval certificates.
Unlike traditional pre-market certification, where products must be assessed before import and sale, these new frameworks place the responsibility on manufacturers to demonstrate ongoing compliance and maintain supporting technical documentation throughout the product lifecycle.
Similar to the European CE requirements, these schemes can accelerate market access and reduce administrative burdens. However, they also increase legal accountability and require more robust evidence to support compliance claims.
As responsibility shifts to manufacturers, the role of accredited laboratories and certification bodies becomes increasingly important, providing technical assurance that transforms self-declarations into credible, evidence-based claims. To avoid product recalls or legal action, manufacturers, importers and distributors are increasingly working with strategic partners like TÜV SÜD to ensure their self-declarations are accurate and compliant.
The specific compliance requirements are not necessarily changing – rather, it is how compliance is demonstrated and who carries the responsibility. Self-declaration is also increasingly becoming a digital declaration, with regulators relying on QR codes, online documentation hubs and market surveillance rather than traditional approval certificates.
LATAM leading the compliance change
LATAM leading the compliance change
In 2025, Argentina started this process by phasing out the mandatory S-Mark for most electrical products in favour of a Declaration of Conformity and QR code marking. Importers must now ensure that QR codes lead directly to the product's official certificate and a Spanish-signed Declaration of Conformity (DoC).
Chile’s telecommunications regulator (SUBTEL) recently moved towards digital self-declaration for short-range wireless devices, typically Wi-Fi and Bluetooth technologies. Formal type approval certificates are being replaced with mandatory QR codes added to product labels, which must link to the product's technical specifications and test reports. Products that have previously been certified must also comply with the new QR label requirements, and a local representative is now mandatory.
Chile’s telecommunications regulator (SUBTEL) recently moved towards digital self-declaration for short-range wireless devices, typically Wi-Fi and Bluetooth technologies. Formal type approval certificates are being replaced with mandatory QR codes added to product labels, which must link to the product's technical specifications and test reports. Products that have previously been certified must also comply with the new QR label requirements, and a local representative is now mandatory.
The changes in Argentina and Chile bring type approval processes closer to the European CE approach, which prioritises speed to market but demands high levels of accuracy in internal documentation and technical files. High-risk items, such as medical wireless devices in Chile or specific toys and high-voltage industrial equipment in Argentina, remain subject to strict third-party certification.
A reallocation of risk ownership and legal accountability
With the current certification model, manufacturers obtain an Approval Certificate for their products prior to entering the country. If renewal is not required, the certificate generally remains valid unless regulatory or product changes trigger additional compliance obligations.
In a self-declaration scheme, manufacturers are responsible for keeping technical documentation on file, available and up to date for verification at any time. Regulators trust these declarations but increase market surveillance activities under this model. Manufacturers, importers and distributors therefore assume greater legal risks, as they no longer have the regulator’s approval certificate acting as a buffer. As such, it is important to ensure that all technical documentation demonstrates compliance with the specific requirements of the target market.
In a self-declaration scheme, manufacturers are responsible for keeping technical documentation on file, available and up to date for verification at any time. Regulators trust these declarations but increase market surveillance activities under this model. Manufacturers, importers and distributors therefore assume greater legal risks, as they no longer have the regulator’s approval certificate acting as a buffer. As such, it is important to ensure that all technical documentation demonstrates compliance with the specific requirements of the target market.
Ensuring compliance in self-declaration schemes
To maintain compliance under self-declaration schemes, manufacturers are recommended to work alongside globally recognised independent laboratories, certification bodies and compliance experts such as TÜV SÜD. This helps ensure that technical documentation is reviewed for compliance, uploaded to the relevant platform or website where required, and made available in Spanish for Latin American markets. Finally, a QR code linked to the relevant documentation must be placed on the product prior to import and sales.
Our dedicated GMA team will assess your product and advise on the next steps required to ensure compliance with the technical regulations of the relevant market. As a local representative is often required, TÜV SÜD can also provide support through trusted local partners and agents. This can save manufacturers, importers and distributors time and money while helping to avoid delays when importing products or planning an international sales strategy.
Potential penalties
The consequences of a false declaration under new digital systems can be more severe and harder to avoid than under paper-based systems. These systems can provide regulators with immediate access to compliance documentation, whereas paper-based systems often rely on manual audits and fixed administrative penalties.
Additionally, as information can be verified online, a revoked certificate, product modification, or other compliance issue may immediately be flagged as invalid when the QR code is scanned. The consequences can be immediate and may result in the detention, confiscation or destruction of goods at customs, as well as significant financial penalties, depending on the country.
Companies may also be prohibited from placing other products on the market. In cases involving public safety risks, intentional interference, or repeated non-compliance with regulatory orders, manufacturers, importers and distributors may face more severe sanctions.
Dealing with the transition from mandatory certification to self-declaration
Self-declaration is becoming digital declaration, as an increasing number of countries like Argentina and Chile now require structured data via QR codes or registries. A common assumption is that the move from third-party certification to self-declaration requires no testing. However, a test report is still required to back up the self-declaration of compliance.
The international Type Approval landscape is fast-moving in terms of regulations, and TÜV SÜD closely monitors these changes to ensure we continue to effectively support manufacturers, importers and distributors across multiple global markets. TÜV SÜD’s Global Market Access (GMA) experts can help to address the challenges of the worldwide shift from a pre-market certification model to a post-market surveillance one.
The international Type Approval landscape is fast-moving in terms of regulations, and TÜV SÜD closely monitors these changes to ensure we continue to effectively support manufacturers, importers and distributors across multiple global markets. TÜV SÜD’s Global Market Access (GMA) experts can help to address the challenges of the worldwide shift from a pre-market certification model to a post-market surveillance one.