In our first wireless compliance webinar, we highlighted the two main pathways to medical device wireless compliance: modular approval and system approval. In our second wireless compliance webinar, we provided an in-depth look at modular approval requirements in the US and Europe so you can determine the best compliance strategy for your product.
In our third wireless compliance webinar, we will take an in-depth look at global market access requirements for 15+ countries in Europe, Asia, Latin America, and beyond. For each country, we will highlight the following:
• Regulator
• Allocated Frequencies for 13.56 MHz, WLAN 2.4 GHz, WLAN 5 GHz
• Modular or System level approval accepted
• Delivery Path: Test Reports accepted (FCC or EU) or In-country Testing
• Number of samples required for submittal
• Local Representative or Importer required for submittal
• Certificate validity
• Average turnaround time to obtain approval
ABOUT THE PRESENTERS:
Maja Bland received her Bachelor of Arts degree in International Relations Global Studies and Spanish Language from the University of Minnesota. In addition, Maja has a Master of Science in Project Management from Saint Mary’s of Minnesota. She recently joined UL’s Global Market Access (GMA) team; however, she has worked in global regulatory trade compliance for 13 years. Maja resides in Minnesota, USA.
Ms. Bland has been dedicated to the field of GMA and she is heavily involved in helping manufacturers with global compliance strategies. Maja and the UL GMA teams work together to leverage UL’s global footprint to ensure a smooth product launch within their target countries. For UL, GMA means integrated solutions for safety & EMC testing, wireless approvals and energy efficiency services. Maja is able to help customers by guiding them through the GMA process every step of the way.
Holly Gillespie is a Global Market Access Operations Leader located in Fremont, California. Holly has been involved in assisting customers develop global compliance strategies for over 20 years. She has twenty five years of experience in the testing, inspection, and certification industry. She values helping customers succeed in the marketplace by partnering with them to develop a compliance strategy to get products to market quickly and efficiently.
在欧盟销售的医疗器械需要拥有一个证明其符合欧盟医疗器械法规的CE认证标志。CE标志表明法定制造商已评估器械，并且符合MDR 2017/745下的一般安全和性能要求（GSPR）。法定制造商将验证是否符合所有相关的欧盟要求，并必须在其欧盟符合性声明（DoC）中声明这一点。此外，高风险器械（MDR下
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