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 regulatory pathway;  move forward with regards to product registration and also requirements for establishment and licensing for local entity in Singapore.
  • 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?
    Fees Class B Class C Class D Class D with registrable drug
    Application fee $515 $515 $515 $515
    Immediate route fee $925 $3090 NA NA
    Expedited route fee NA $3090 $5560 NA
    Abridged route fee $1850 $3605 $5870 $10200
    Full route fee $3605 $5870 $11600 $75200
    Full route (Priority review scheme route 1) $4100 $6600 $13200 NA
    Full route (Priority review scheme route 2) $5300 $8600 $17100 NA

     

    For more information, please click here.

  • How long does it take for my product to be approved by HSA?

    Turnaround time (working days)

    Registration route Class B Class C Class D Class D with registrable drug
    Immediate route Immediate upon submission Immediate upon submission NA NA
    Expedited route NA 120 180 NA
    Abridged 100 160 220 220
    Full route 160 220 310 310
    Full route (Priority review scheme route 1) 120 165 235 NA
    Full route (Priority review scheme route 2) 120 165 235 NA

    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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