What is Pure Global?
Regulatory approval navigated for medical devices.
Who is Pure Global best for?
Pure Global is best for medical device and IVD makers that need registration and local representation in 30+ countries.
Device makers entering several countries
One firm handles registration and local representation in more than 30 markets, and a public calculator shows the yearly fee for each one.
Makers without a local office
Pure Global acts as the required in-country representative, from US Agent to EU representative, and deals with the health authorities for you.
Quality and audit work
ISO 13485 and FDA QMSR consulting, supplier audits and device cybersecurity support sit alongside the registration service.
Regulatory research on a budget
Free databases cover device registrations, clinical trials, regulations, approval timelines and government fees across markets.
How much does Pure Global cost?
Pure Global charges a flat yearly fee per device listing in each market, from $1,000 a year in the US and $2,000 to $3,000 a year in most other markets, plus government fees, on a three-year contract.
- Acts as your US Agent and Official Correspondent
- Help with FDA establishment registration and the yearly FDA fee
- 510(k) and other premarket submissions cost extra
- Representation under EU MDR or IVDR, with EUDAMED support
- Up to $4,000 a year for five device groups
- Technical documentation file costs extra
- Brazil, Mexico, Singapore, Vietnam and more
- Dossier preparation, submission and local-language translation
- Local representation, renewals, changes and post-market support
- Brazil, Mexico, Malaysia, Thailand and more
- Same services as the low or medium risk fee
- Pakistan is $3,000 for every risk class
The UK and Australia start at $2,000 a year and Switzerland at $2,500, on the same device-group terms as the EU. Government and other third-party fees are extra, and dossier preparation is not included in the US, EU, UK, Switzerland or Australia. Each extra listing costs less than the first; more than 10 listings, or markets outside the 18 in the fee calculator, are priced on request. A three-year contract is required: a one-year contract costs 50% more in the first year, and leaving early costs half of the remaining contract value. Thailand and Indonesia add an import fee of 2% of the import value, from $300 to $1,000 each time. Pure Global's databases and AI tools on its Pure Global AI site are free. Full pricing on pureglobal.com. We checked these prices on .
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Questions about Pure Global
What does Pure Global's yearly fee leave out?
Pure Global's flat fee leaves out government and other third-party fees, translations into English, marketing and certified translations, and dossier preparation in the US, EU, UK, Switzerland and Australia, which is sold separately at a fixed rate.
Who is Pure Global for?
Pure Global is best for medical device and IVD makers that need registration and local representation in 30+ countries.
Is Pure Global free?
No, Pure Global's registration and representation service is paid, from $1,000 a year per device listing in the US and $2,000 to $3,000 elsewhere. Its separate Pure Global AI site offers free databases of device registrations, clinical trials, regulations and government fees.
How much does Pure Global cost?
Pure Global's paid plans are United States at From $1,000 per device listing per year, European Union at From $2,000 per year for one device group, Other markets, low or medium risk at From $2,000 per device listing per year and Other markets, medium or high risk at From $3,000 per device listing per year.
Where can I try Pure Global?
On its official website, pureglobal.com.
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