In Singapore, Medical Devices are regulated by the Health Sciences Authority (HSA) under the Ministry of Health (MOH). All medical products must be registered with HSA before being marketed in Singapore. Medical devices in Singapore are divided into four classes (A, B, C and D) based on risk level. To register a medical device, a company must have an office or a local distributor in Singapore registered with the MOH.

Our country specific (*) services in Singapore include:

Medical Device specific regulation strategy reports, Medical Device Registration with the MOH, Singaporean Representative and certification holder for Medical Device manufacturers, Technical Dossier preparation, GMP audit compliance and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Singapore!

(*) Singaporean Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service.