Frequently Asked Questions

  • I wish to set up a Quality Management System for my company. Can I obtain advisory service from a 3rd party consultant to assist me?
    Contact us. We guide and assist you in setting up, implementing and auditing a Quality Management System for certification to comply with the International Standards and requirements. e.g. GDPMDS, ISO 13485, US FDA 21 CFR Part 820 and etc.
  • I am a distributor and wish to import medical devices into a country in the region. I wish to understand the local regulatory requirements.
    Contact us. We can advise you on the local regulations and advise on the strategy to move forward with regards to product registration.
  • How do I classify or group the product range in the Medical Devices that I am handling with regards to registration to meet the new regulations ?
    Contact us. We will assist you in classifying and grouping for Medical Devices product registration.
  • Where can I find a professional trainer to train my staff with regards to understanding the current regulatory issues?
    Contact us. We provide in-house/external training program that suits your professional needs, company goals, and preferred learning style. We can train in the following areas as in ISO 13485, Risk Management & US FDA 21 CFR Part 820.
  • How much is the product registration fee in Singapore?
    RISK CLASS APPLICATION FEES EVALUATION FEES
        IBR Expedited Abridged Full
    Class A (Non-Exempt) $25
    Class B $500 $900 $900 $1,800 $3,500
    Class C $500 $3,000 $3,500 $5,700
    Class D $500 $5,400 $5,700 $11,400
    Class D, devices incorporating medicinal products $500 $10,000 $75,000

    Source of data from Health Science Authority (HSA).

    For more information, please click here.

  • How long does it take for my product to be approved by HSA?
    RISK CLASSIFICATION TAT FOR REGISTRATION (IN WORKING DAYS)
    Class A (sterile)  30

     

    RISK CLASS TAT FOR REGISTRATION (IN WORKING DAYS)
      Immediate Expedited Abridged Full
    Class B Immediate Registration upon Submission 60 100 160
    Class C 120 160 220
    Class D 180 220 310
    Class D, devices incorporating medicinal products 220 310

    Source of data from Health Science Authority (HSA).

    For more information, please click here.

 

 

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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