Global Market Access
UL's Global Market Access (GMA) program delivers real value, all over the world.
- One test plan allows you to certify your product for entry into new markets
- Avoid complexity and confusion in the global certification process
- Save effort and resources in accessing markets around the world
What does GMA mean for your business?
As your one-stop resource for product certification, UL makes it easier for you to do what you do best -- make and sell high quality medical devices. Here's how our GMA program works:
- UL is accredited to provide Marks recognized around the world. With just one product submission, you receive multiple market-specific marks of safety indicating your products' compliance with local and global regulations and industry standards.
- Because UL gives you access to markets around the world, administrative and project management activities are cut to a minimum. Your resources (people, time, and money) are freed for more value-added work. Our flexible solutions fit your business: UL project management and technical teams are "feet on the ground," dedicated to your success in both domestic and foreign markets.
- A UL-bestowed mark is a strong credential with stakeholders -- customers, management, supply chain partners, employees, and regulators. Safety marks increase the value of your product; discerning customers have a choice, and they choose products that are certified by a source they trust.
Earn regulatory approvals through UL
UL's Global Market Access services go beyond certification marks and testing. Use your test reports to submit for global regulatory approvals for the major medical markets.
- United States -- As an FDA Accredited Person, save time by submitting your 510(k) review through UL
- Japan -- UL can assess certain medical devices for Japan regulatory approvals and integrate the Japan Quality requirements into your ISO 13485 audit
- Europe -- Take advantage of local Notified Body auditors and technical file assessments by using UL as your Notified Body for the MDD and IVDD
- China -- Leverage UL's experience in regulatory submittals to China's SFDA to save time
- Global -- Meet global quality system requirements through UL's integrated ISO 13485 and ISO 14971 Registration services
