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Osmunda Medical Device Service Group
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Osmunda Medical Device Service Group

Osmunda Medical Device Service Group

Guangdong, Mainland China

Service Company

Average Response Time

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Medical Device Registration
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Description
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.

Osmunda Medical Device Service Group

Osmunda Medical Device Service Group

Guangdong, Mainland China

Service Company

Average Response Time

N/A

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