Streamline access to your target markets by leveraging UL’s local presence and worldwide expertise. Your in-county team will provide guidance and support to help you stay abreast of evolving regulations.
All medical devices sold must register with the ANVISA who perform all registration and inspection functions within the agency.
A team of in-house UL experts working in China to help you with China Approvals
The Notified Body system calls for medical devices of moderate to high risk to be assessed by an independent third party.
Public health regulations primarily apply to pharmaceutical devices under the Ministry of Health and Family Welfare’s CDSCO.
Importers must appoint a MAH as their legal representative in Japan and are subject to an annual quality management system audit.
With influential multi-national companies leading the tech sector in South Korea, there is also a thriving medtech industry in-country.
Bringing a device to market may require additional approvals from the FDA, FCC, FTC, OSHA, and acceptance from health insurance provide
There is intense pressure to get every sale to make up for the huge investment in R&D and regulatory approvals. New markets are o
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