Regulatory Affairs Services

  • Medical device regulatory affairs requires full time (or overtime) attention due to the myriad of new regulations /changes underway and/or forthcoming (MDR and IVDR are prime examples).
  • For medical device companies who also have to access to Asia region, the region does not have an equivalent of CE for Europe. This means that medical device companies have to submit to each and every regulatory agency for the Asia region (from China,  Taiwan, Japan, South Korea, Australia/NZ and to each  ASEAN country).
  • As for ASEAN  countries, each country has a different pace of adoption and rollout of AMDD.
  • DH RegSys Regulatory Affairs team has and will continue to help our clients from multi-directions including
    • CE and US FDA approval 
    • China NMPA approval
    • major ASEAN countries like Indonesia, Thailand, Vietnam, Philippines, Malaysia
    • Taiwan 
    • South Korea
    • Japan
OUR PARTNER
  • MD-CLINICALS Europe

    Route de Denges 28C
    1027 Lonay
    Switzerland

    Phone: +41 21 349 96 36
    Mobile: +65 98656730
    Fax: +41 21 349 96 37
    Site: www.md-clinicals.com
Call us at 6659 0979
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