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Traditional medicines
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Chinese proprietary medicines
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  • Fees and Turnaround time of Chinese Proprietary Medicines
Cosmetic products
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Tobacco regulation
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CTGTP
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Register your device
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Dealer's licensing and certification
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  • Apply for a Chinese Proprietary Medicine dealer's licence
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  • Good Manufacturing Practice and Good Distribution Practice Standards
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  • Import for re-export of Chinese Proprietary Medicines
Cosmetic product notification​
  • Submit notification and re-notification
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Register a Class 2 CTGTP
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​Dealer's licensing and certification
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Certification of local dealers
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Registration overview
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​Special Access Routes (SAR)
  • Import and supply of unregistered Class 2 CTGTP
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Certification of local dealers
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  1. Home
  2. Medical devices

Importer, wholesaler and manufacturers' licensing

You need a dealer's licence if you manufacture, import or wholesale medical devices in Singapore.

Apply for a licence You need to use MEDICS to apply for a dealer's licence. This includes the manufacturer, importer and wholesaler's licences. Amend a licence You must notify us of changes to your dealer's licence on details such as medical device risk classification, QMS certification and company details. Renew or cancel a licence Renew your dealer's licence on time to continue dealing in medical devices in Singapore. Good Distribution Practice for Medical Devices Dealers must have a Quality Management System that meets requirements to ensure the safety, quality and performance of medical devices they are dealing in.
Last updated: 31 Dec 2018
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Medical devices

  • Regulatory overview

  • Register your device

  • Changes to registered devices

  • Dealer's licence

  • Free Sale Certificate and Export Certificate

  • Custom-made medical devices

  • Report adverse events

  • Field Safety Corrective Action reporting

  • Clinical trials

  • Consultation schemes

  • Advertisements and promotions

  • Bringing personal medical devices into Singapore

  • COVID-19: Standards Resources for Essential Medical Devices

  • Digital Health

  • International collaboration

  • Standards for Medical Devices

  • Guidance documents

  • Fees and turnaround time

  • Registration and licensing tools

  • MEDICS

  • Infosearch

Medical devices

  • Regulatory overview

  • Register your device

  • Changes to registered devices

  • Dealer's licence

  • Free Sale Certificate and Export Certificate

  • Custom-made medical devices

  • Report adverse events

  • Field Safety Corrective Action reporting

  • Clinical trials

  • Consultation schemes

  • Advertisements and promotions

  • Bringing personal medical devices into Singapore

  • COVID-19: Standards Resources for Essential Medical Devices

  • Digital Health

  • International collaboration

  • Standards for Medical Devices

  • Guidance documents

  • Fees and turnaround time

  • Registration and licensing tools

  • MEDICS

  • Infosearch

 
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Last Updated 03 Sep 2019