Registration of medical products in Asia can be a challenging and sometimes demoralizing task. Obtaining local FDA regulatory approval is one of the major "entry barriers" to important medical device in Asia. Most foreign medical device companies try to obtain regulatory approval in Asian countries through:

  • A multinational Regulatory consultancy company in their home country
  • A registration agent in the target market typically located in the capital
  • A "Freelance Regulatory Affair (RA) agent"
  • Distributor in the country

    Class I & II medical device registration in Japan, South Korea and China ¡°officially¡± requires less than one year. However, the reality is very far from that! E.g. thousands of medical devices apply for registration with the Chinese SFDA and close to half never get the approval after years of investment on time and money.


    WHY? The main bottleneck is often not the local FDA requirements, but communication with and management of the registration agents. HMC¡¯s Consultants have the real world experience of obtaining registration of different medical devices with the MOH in Japan, KFDA in South Korea and SFDA in China. HMC consultants will not provide you with a voluminous list of ¡®local FDA requirements which seems impossible to fulfill, but offer:

  • Tailor made online training and Q&A session for the RA specialists in your HQs
  • Critical Success Factors (CSF) and potential problems related to YOUR products
  • Feasibility study ¨C review of available documents; success probability & risk assessment


    If the decision is to go ahead, HMC consultants will provide you with:

  • A selection and evaluation of different registration agents based on YOUR product and RA
  • Negotiate a result-oriented contract with the chosen registration agent on your behalf
  • Manage the local registration agent and the whole registration process to ensure realistic timeline is met

    HMC your "one stop" partner in Regulatory Affairs


     
     
         
         
     
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