If your company is exporting medical devices to Taiwan you will be happy to learn that DGM has been designated to be a partner in the Technical Cooperation Programme on exchange of audit reports between the EU and Taiwan. Using DGM as your Notified Body in this programme you can reduce time and cost in demonstrating compliance with regulatory requirements.

As of February 2004 it became mandatory that all companies exporting medical devices to Taiwan comply with the Taiwan Medical Device Regulations (TMDR). For many manufacturers this process has proven to be very slow and cause delays to market access.

On a practical basis European manufacturers can obtain marketing permission to Taiwan by having one of the Taiwanese organisations accept the following documentation:

• recent DGM 13485 audit report
  
  
• an accredited certificate
  
  
• a cover letter
  
  
• free sale certificate