Osmunda Medical Device Service Group

Medical Device Registration

All medical devices are required to obtain pre-market approval from the Chinese State Food and Drug Administration (SFDA). This medical device registration provides SFDA registration consultation for class I, Ⅱ and Ⅲ medical devices. All medial devices will be certified to meet with the EU and CE safety standards.
 
  SFDA registration consultation for IVD. 
  SFDA import registration. 
  EU, CE (MDD, IVDD, PPE, AIMDD). 
  US FDA (Listing, 510k, PMA). 
  CMDCAS/TGA/JPAL/KFDA/Brazil. 
 

<img src="https://sourcing-media.hktdc.com/product/8ae545a8e39d11ea883f06c82c63b760/97d55142e39d11ea883f06c82c63b760" class="fr-fic fr-dib" data-strproductmediaid="18f9d6e8e39e11ea883f06c82c63b760">

All medical devices are required to obtain pre-market approval from the Chinese State Food and Drug Administration (SFDA). This medical device registration provides SFDA registration consultation for class I, Ⅱ and Ⅲ medical devices. All medial devices will be certified to meet with the EU and CE safety standards.
<ul>
    <li>SFDA registration consultation for IVD.</li>
    <li>SFDA import registration.</li>
    <li>EU, CE (MDD, IVDD, PPE, AIMDD).</li>
    <li>US FDA (Listing, 510k, PMA).</li>
    <li>CMDCAS/TGA/JPAL/KFDA/Brazil.</li>
</ul>

Osmunda Medical Device Service Group, as the leading clinical trial CRO and integrated service provider of medical device in China, only focuses on the field of medical device. Founded in 2004, Osmunda has set up seven subsidiaries in China and the U.S, with over 150 employees and the headquarter in Guangzhou. Comprehensive Service Chain: Osmunda provides the services of medical device clinical trial, global registration of medical device, data management and medical device consultation, covering the whole service chain in medical device industry. We are providing a comprehensive one-stop solution based on medical device clinical trial for medical device enterprises. Powerful Technical Services: Osmunda has established a database of medical device industry and an online management system of the consulting projects. We have built up a good partnership and friendship with many clinical bases, notified bodies, testing agencies and industry associations, etc., forming a powerful technical service network. Over 2,000 domestic and foreign medical device enterprises have selected and recognized our professional services.

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Osmunda Medical Device Service Group

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