5.0 Product Profiles

5.5 Regulatory Milestones

5.51 The US should be listed first. Please reference the Clinical/Regulatory section for details.

5.52 The Regulatory Milestones region, path and status should match the Regulatory Status section. The Regulatory Status section might have more details such as a date or small description if there is more than one in a region.
  US Regulatory  
Region Path Status
US 510 (k) Cleared
US Class I Exempt
     
  OUS Regulatory  
Region Path Status
Argentina ANMAT Approved
Australia TGA Approved
Brazil ANVISA Approved
Canada Health Canada Issued
Chile ISP Approved
China NMPA Approved
EU CE Mark Issued
EU EMEA Clinicals
India CE Mark Issued
India Genetic Engineering Approval Committee Approved
India New Delhi and State Drug Control Administration Approved
India Ministry of Environmental and Forests Approved
India DCGI Approved
India CDSCO Approved
Israel Israel Ministry of Health Approved
Japan MHLW Approved
Mexico    
Netherlands Human Tissue On Market
Netherlands ISO Certification Issued
New Zealand WAND Registered
New Zealand Medsafe Approved
Singapore Heath Sciences Authority Registered/Approved
South Korea MFDS Approved
Sweden Medical Products Agency Approved
Taiwan Taiwan DOH Approved
Thailand Thai FDA Cleared
UK 510 (k) Cleared
UK CE Mark Issued

 

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