Your medical device and IVD approvals in the US and EU can streamline pathways in 25+ markets worldwide, from Australia and Switzerland to Brazil and Singapore, cutting the time and cost of international expansion. And with AI-powered tools now helping regulatory specialists build submissions up to 50% faster, scaling your device portfolio across borders has never been more achievable.
International expansion for medical device and IVD companies can be intimidating, particularly for startups and mid-sized firms. Many invest thousands in EU or US compliance with no plans to expand because they expect a similarly grueling and expensive process in other markets. However, the logistics of global submissions have shifted. There are more similarities between market requirements than ever, which means less friction and more leverage opportunities for manufacturers with CE Marking or FDA clearance.
Using your existing FDA approval or CE marking as a foundation can bypass or shorten the submission preparation process in more than 25 additional markets. In some cases, it can even expedite the regulatory review and approval timeline. By prioritizing markets that offer these pathways, manufacturers can secure approvals with time and cost efficiency.
For example, let’s look at how CE Marking is leveraged in Switzerland and Australia:
Switzerland has its own medical device (MedDO – Medical Device Ordinance) and IVD (IvDO – In Vitro Diagnostic Ordinance) regulations and is not part of the EU. But EU CE Marking is a requirement to sell medical devices and IVDs in Switzerland. If your device bears the CE Mark, additional local regulatory requirements in Switzerland are minimal and there is no formal approval process. Foreign manufacturers must appoint a Swiss Authorized Rep (CH-REP), who must be registered as an Economic Operator in Switzerland. The CH-REP will then review and register all devices represented in Swissdamed. CE Certificates must be kept up to date, and post-market surveillance and adverse event reporting obligations must be met.
In Australia, all devices must wait for formal approval from Therapeutic Goods Administration (TGA) to be included in the Australian Register of Therapeutic Goods (ARTG) before supplying devices in Australia. However, TGA accepts documentation from approvals in specific markets for abridged review. Documentation requirements for this process are the most minimal for medical devices and IVDs leveraging MDR/IVDR CE Marking compared to any other accepted reference market. TGA still conducts a formal review of your submission, and discrepancies can still trigger an application audit, which can prolong the review process.
EU MDR and IVDR CE Marking gives you the most flexibility globally as more regulators are harmonizing classification rules, clinical evidence requirements, and documentation requirements to the EU framework:
FDA clearance gives you slightly less runway, as FDA classification differs from most markets in its application (substantial equivalence versus a rules-based system) and structure (three classification tiers instead of four). However, there are still high-growth opportunities to leverage your FDA 510(k) clearance or Premarket Approval (PMA), especially if you also hold a Medical Device Single Audit Program (MDSAP) certificate with the appropriate scope.
Note that almost all markets require foreign manufacturers to appoint an in-country representative. Your in-country representative submits your documentation to the regulatory authority and acts as a liaison throughout the registration process and post market.
Even where your FDA or CE approval can be leveraged, there are still local requirements to be met and a formal submission process. Your existing technical documentation may be accepted without major reformatting; however, there is usually a standard application form that requires detailed information about your medical device. These forms can still take hours to complete and require deep knowledge of your device, its characteristics, and expectations in the destination market. Filling submissions for your entire device portfolio across multiple markets can quickly rack up dozens, if not hundreds, of man hours.
AI-supported submissions are further closing that gap. Regulatory affairs (RA) specialists can compile submissions 50% faster with AI-supported tools that do the foundational work of extracting data from your existing documentation, and complete a draft of your submission. For example, in the case of Brazil, an RA specialist can initiate a gap analysis or pre-fill an ANVISA registration form with the use of AI-supported tools, while focusing on high-level strategy or clinical evaluations. Once completed, the regulatory expert can then review and validate the drafted analysis and submission form for any discrepancies.
If you have FDA or CE approvals for your medical devices, you’ve already done the bulk of the work. With the right partner, your existing documentation can be repurposed in dozens of markets with minimal lead time. Pure Global’s international team of regulatory experts is leveraging the support of AI tools to help medical device and IVD manufacturers expand to the biggest medical device and IVD markets. Here’s how we do it:
Expanding beyond your home market? Our regulatory team can map out which markets your existing approvals unlock and what it takes to get there. Talk to an expert.
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