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Simple, Transparent Pricing for Global Medical Device Registration

Accelerate market entry with AI-powered dossier compilation and local regulatory representation, all for a flat annual fee. Plan your global market entry budget with a few clicks. Use our Fee Calculator to get your instant estimate.

Predictable Annual Fees

Starting at $2,000 USD per year for the first device (excluding government fees).

All-Inclusive Support

Dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.

Turnkey Registration in Key Markets

Our flat-fee pricing structure is offered in 14 major medical device markets worldwide.

pricing calculator

Calculate Your Price

Select your target markets, device classification, and number of devices to generate an instant estimate. Pricing updates automatically as you adjust your selections.

Complete Service Package

What's Included in Your Flat Annual Fee?

As your In-country Representative, everything you need for medical device & IVD registration

Dossier Preparation

We compile and submit your dossier in half the time using our AI-powered workflows and in-house expertise.

In-Country Representation

Local regulatory experts interface directly with health authorities on your behalf as your legal representative.

Translation Services

Dossier preparation includes localization from English for submission documents where required. Certified translations are not included.

Modifications & Renewals

Compliant and on-time filing for device modifications and registration renewals.

Importer Authorization

Generate import authorizations to local distributors and importers, where applicable.

Post-Market Support

Support for post-market surveillance, vigilance, reporting, and ongoing regulatory obligations.

* Government fees not included

Government fees and other required third-party fees are not included, but we can help you estimate these costs.

* Custom pricing for large portfolios

Registering more than 10 devices? We will create a custom pricing estimate for your needs.

* Three-year contract required

Early contract termination is possible with 50% payoff of the remaining contract value. If you prefer a one-year contract, pay a 50% higher fee in the first year.

OUR COMMITMENT

Clear benefits of flat-fee pricing

After 20+ years in MedTech regulatory services, we believe pricing should be simple, fair, and transparent.

Budget with Confidence

Know exactly what you'll pay before you commit.

Compare Markets

Instantly evaluate market costs side-by-side.

Scale Efficiently

See pricing for 1 to 10 listings so you can plan your portfolio expansion.

Instant Self-Service

No need to wait for quotes. Get your pricing immediately.

Pricing Questions Answered

What exactly is included in the annual fee?

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

What is explicitly not included in the flat annual fee?

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

What is the starting flat fee price?

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

Which markets offer flat fee pricing?

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.

What factors affect my annual fees?

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.

Are government or authority fees included?

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

Are translations included?

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.

Does Pure Global act as the in-country representative?

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

Is there a minimum contract term?

Yes. A three-year contract is required.

Can I terminate early?

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

Can I choose a one-year contract?

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

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.