Simple, Transparent Pricing for Global Medical Device Registration

The flat annual fee includes:

• In-country regulatory representation
• Device registration compilation*
• Dossier submission to local authorities
• Translations from English to the local language for required submission documents
• Import authorizations for local distributors, where applicable
• Post-approval modifications
• Annual renewals
• Post-market surveillance correspondence with authorities

_{*Not included in the US, EU, UK, Switzerland, and Australia. Dossier compilation available separately for a fixed rate.}

The following are excluded:

• Government and third-party fees
• Importation handling by the in-country representative
• Translations into English
• Marketing material translations
• Certified translations required by authorities

Medical device and IVD registration services start at $2,000 USD per year, depending on device risk level, number of listings, and selected markets.

Flat fee pricing is available for 14 global markets, including Brazil, Colombia, Mexico, the United States*, the European Union*, Switzerland*, the United Kingdom*, Australia*, Hong Kong, Indonesia, Malaysia, Singapore, Thailand, and Vietnam.

Pure Global supports 30+ global markets. Pricing for additional markets is customized based on regulatory scope.

_{*Flat fee pricing excludes dossier preparation in US, EU, UK, Switzerland, and Australia. Available separately for a fixed rate.}

Your annual fee is based on:

• Number of device listings (1–10 standard)
• Device risk level (low/medium or medium/high)
• Selected markets

Portfolios with more than 10 listings require custom pricing.

No. Government fees and required third-party fees are not included in the annual fee and are billed separately.

Translations from English to the local language for regulatory submission documents are included.

The following are not included:

• Translations into English
• Marketing material translations
• Certified translations required by authorities

These services are available for an additional fee.

Yes. Where required, Pure Global serves as the authorized in-country representative and manages all regulatory correspondence with local authorities.

Yes. A three-year contract is required.

Yes. Early termination is permitted with a 50% payoff of the remaining contract value.

Yes. One-year contracts are available with a 50% higher fee in the first year.

Flat-fee pricing for the EU starts at $2,000 USD per year for one device group and scales to $4,000 USD for five device groups*. This fee includes:

• Ongoing regulatory representation under EU MDR or IVDR
• Review of prepared documentation
• Support with EUDAMED registration and maintenance**
• Free Sale Certificate (FSC) requests

Compilation of the Technical Documentation File is not included in the annual fee and is offered separately at a fixed rate.

_{*Pricing structure also applies in the UK, Australia, and Switzerland.}

_{**MHRA Portal registration in the UK, ARTG registration in Australia, and Swissdamed registration in Switzerland are included in the annual fees for these markets.}

Flat-fee pricing for the US starts at $1,000 USD per year and covers:

• Representation as your Official Correspondent and US Agent
• Support for FDA establishment registration
• Guidance on FDA annual user fee processing

Compilation of 510(k) or other premarket submissions are not included in the flat fee. These services are available separately at a fixed rate.