Skip to main content
Singapore GovernmentA Singapore Government Agency Website
Health Sciences Authority
Products regulation Blood donation Lab services Who we are E-services
  • E-services
  • Product Regulations
    • Medical devices
    • Therapeutic products
    • Health supplements
    • Traditional medicines
    • Chinese proprietary medicines
    • Cosmetic products
    • Tobacco regulation
    • CTGTP
  • More Regulations
    • Clinical trials
    • ​Controlled drugs and psychotropic substances
    • Poisons
    • Homoeopathic medicines
    • Medicated oils and balms
    • Topical antiseptics
    • Advertisements and promotions of medicinal products
    • International collaboration
  • Report adverse events
  • Blood donation
  • Lab services
  • Who we are
Medical devices
  • Regulatory overview
  • Register your device
  • Changes to registered devices
  • Dealer's licence
  • Free Sales Certificate and Export Certificate
  • Report adverse events
  • Field Safety Corrective Action reporting
  • Clinical trials
  • Consultation schemes
  • Advertisements and promotions
  • Bringing personal medical devices into Singapore
  • Guidance documents
  • Fees and turnaround time
  • COVID-19: Standards Resources for Essential Medical Devices
  • Digital Health
  • International collaboration
Therapeutic products
  • Regulatory overview
  • Register your product
  • Listing of approvals and post-registration actions
  • Apply for post-approval variation
  • ​Reclassify your product
  • ​Dealer's licensing and certification
  • Apply for retention, cancellation or transfer application
  • Report adverse events
  • Report or recall defective products
  • ​Retail pharmacy licensing
  • Clinical trials
  • Product consultation
  • Advertisements and promotions
  • ​CPP and SLS
  • International collaboration
  • Medicines quality and compliance monitoring
  • Guidance documents
  • Fees and turnaround time
Health supplements
  • Regulatory overview
  • Voluntary Notification of HS and TM
  • List of Notified HS and TM
  • Health supplement claims
  • Advertisements and promotions
  • Report adverse events
  • International collaboration
Traditional medicines
  • Regulatory overview
  • Voluntary Notification of HS and TM
  • List of Notified HS and TM
  • Advertisements and promotions
  • Report adverse events
  • Traditional medicinal materials
  • International collaboration
Chinese proprietary medicines
  • Regulatory overview
  • Product listing
  • Dealer's licensing and certification
  • Free Sale Certificate
  • Advertisements and promotions
  • Report adverse events
  • Traditional medicinal materials
  • Fees and Turnaround time of Chinese Proprietary Medicines
  • International collaboration
Cosmetic products
  • Regulatory overview
  • Cosmetic product notification​
  • ASEAN Cosmetic Directive
  • Good Manufacturing Practice certification for cosmetic products
  • Report adverse events
  • Fees and turnaround time
Tobacco regulation
  • Overview of tobacco control
  • Tobacco licences
  • List of suspended and revoked licences
  • Report tobacco-related offences
  • Fees and turnaround time
  • Tobacco retailer educational video and quiz
CTGTP
  • Regulatory overview
  • Class 1 CTGTP notification
  • Register a Class 2 CTGTP
  • Variation applications
  • Dealer's notice
  • ​Dealer's licensing and certification
  • Report adverse events
  • Report or recall defective products
  • Clinical trials
  • Product consultation
  • Advertisements and promotions
  • Certificate of a Pharmaceutical Product
  • Guidance documents
  • Fees and turnaround time
  • Register of Class 2 CTGTP
  • Notified Class 1 CTGTP
  • Register of Licensed CTGTP Importers, Wholesalers and Manufacturers
Bringing personal medications into Singapore
  • Regulations for bringing in personal medications
  • Check medication requirements
  • Apply for approval
Clinical trials
  • Regulatory overview
  • CTA, CTN or CTC submissions
  • Submit a CRM notification
  • Good Clinical Practice Inspections
  • Report adverse events
  • Innovation Office
  • Conducting clinical trials
  • Participating in clinical trials
  • Guidance documents
  • Clinical Trials Register
  • Clinical trials statistics
​Controlled drugs and psychotropic substances
  • Controlled drugs​
  • Psychotropic substances
  • Restricted substances
  • Fees and turnaround time
Poisons
  • Overview of Form A Poisons Licence
  • Apply for a licence
  • Amend a licence
  • Renew or cancel a licence
  • Fees and turnaround time
Topical antiseptics
  • Regulatory overview
  • Topical antiseptics classification guide
  • Guidance for suppliers of hand sanitisers
International collaboration
  • Therapeutic products
  • Medical devices
  • Complementary health products
E-services
  • Infosearch
  • HSA PIN
Consumer safety
  • Articles
  • Make a report
​Why join HSA
  • Apply for a job
  • Sponsorship for Diploma in Nursing
  • Employment benefits
  • Articles
  • Forensic Odontology Scholarship
Register your device
  • Registration overview
  • Is it a medical device Tool
  • Risk classification rules and factors
  • Risk classification tool Tool
  • Registration and licensing requirements Tool
  • Medical device grouping tool Tool
  • Grouping medical devices
  • Registration guides
  • Priority Review Scheme
  • ​Special Access Routes
Dealer's licence
  • Apply for a licence
  • Amend a licence
  • Renew or cancel a licence
  • Good Distribution Practice for Medical Devices
Field Safety Corrective Action reporting
  • When to report
  • How to report
  • Risk management
International collaboration
  • IMDRF
  • AMDC
Register your product
  • Registration overview
  • ​Registration guides for therapeutic products
  • Summary Reports of Benefit-Risk Assessment
  • ​Special Access Routes (SAR)
  • GMP conformity assessment of overseas manufacturers
  • Lot release for imported vaccines
  • Pre-submission Consultation Mechanisms
Apply for post-approval variation
  • Overview of variation application types
  • ​Major variation (MAV-1) application
  • ​Major variation (MAV-2) application
  • Minor variation (MIV) application
  • Minor variation (MIV) self-guided tool
​Reclassify your product
  • Apply for reclassification
  • Preparations allowed as General Sale List
  • List of reclassified medicines
​Dealer's licensing and certification
  • Overview of dealer's licences
  • Apply for a licence
  • Amend a licence
  • Renew or cancel a licence
  • Good Manufacturing Practice and Good Distribution Practice Standards
  • Certification of local dealers
  • Handling of Applications and Conduct of Inspections During COVID-19
​Retail pharmacy licensing
  • Overview of retail pharmacy licence
  • Apply for a retail pharmacy licence
  • Amend a retail pharmacy licence
  • Renew or cancel a retail pharmacy licence
  • Compounding of therapeutic products
  • Supply GSLs via vending machines
  • Supply of registered therapeutic products through e-pharmacy
Clinical trials
  • Regulatory overview
  • New CTA or CTN submission
  • Subsequent submissions
  • Good Clinical Practice Inspections
  • Report adverse events
  • Product consultation
  • Conducting clinical trials
  • Clinical Trials Register
  • Clinical trials statistics
​CPP and SLS
  • Certificate of a Pharmaceutical Product
  • Statement of Licensing Status
International collaboration
  • Access Consortium
  • ICH
  • ICMRA
  • NPRA
  • ASEAN Joint Assessment Procedure
Medicines quality and compliance monitoring
  • Nitrosamine impurities in medicines
  • Product Quality Surveillance for therapeutic products
Product listing
  • Apply for new product listing
  • Amend or cancel product listing
  • Transfer product listing
  • Responsibilities of a CPM dealer
Dealer's licensing and certification
  • Overview of dealer's licences
  • Apply for a Chinese Proprietary Medicine dealer's licence
  • Amend a Chinese Proprietary Medicine dealer's licence
  • Renew or cancel a licence
  • Good Manufacturing Practice and Good Distribution Practice
  • Certification of local dealers
  • Import for re-export of Chinese Proprietary Medicines
  • Handling of Applications and Conduct of Inspections During COVID-19
Cosmetic product notification​
  • Submit notification and re-notification
  • Update or cancel notification
Tobacco licences
  • Tobacco retail licence
  • ​Tobacco import and wholesale licence
Register a Class 2 CTGTP
  • Registration overview
  • ​Registration guides for Class 2 CTGTP
  • ​Special Access Routes (SAR)
  • GMP conformity assessment of overseas manufacturers
Variation applications
  • Overview of variation applications
  • MAV -1 application
  • MIV-1 and MIV-2 applications
​Dealer's licensing and certification
  • Overview of dealer's licences
  • Apply for a licence
  • Amend a licence
  • Renew or cancel a licence
  • Good Manufacturing Practice and Good Distribution Practice Standards
  • Certification of local dealers
Clinical trials
  • Regulatory overview
  • New CTA or CTN submission
  • Subsequent submissions
  • Good Clinical Practice Inspections
  • Report adverse events
  • Product consultation
  • Conducting clinical trials
  • Clinical Trials Register
  • Clinical trials statistics
CTA, CTN or CTC submissions
  • New CTA or CTN submission
  • New CTC submission
  • Subsequent submissions
Conducting clinical trials
  • Study staff
  • Sponsor
  • ​Informed consent
  • ​Investigational and auxiliary products
  • ​Investigator Site File
  • ​Template forms
Controlled drugs​
  • Apply for a controlled drugs licence
  • Amend licence to wholesale or manufacture controlled drugs
  • Renew or cancel a licence
Therapeutic products
  • Access
  • ICH
  • ICMRA
  • NPRA
Medical devices
  • IMDRF
  • AMDC
Complementary health products
  • Access
  • ASEAN TMHS
Articles
  • Details
Articles
  • Details
Grouping medical devices
  • Dental Grouping Terms (DGT)
  • Hearing aids
  • Immunohistochemistry (IHC) IVD reagents
  • Fluorescence in situ hybridisation (FISH) probes IVD
  • IVD analysers
  • In vitro fertilisation (IVF) media
  • Family
  • System
  • Group
  • Single
  • IVD Test Kit
  • IVD cluster
Registration guides
  • Class B full registration
  • Class B abridged registration
  • Class B immediate registration
  • Class C full registration
  • Class C abridged registration
  • Class C expedited registration
  • Class C immediate registration
  • Class D full registration
  • Class D abridged registration
  • Class D expedited registration
  • Class D with a registrable drug in a secondary role full registration
  • Class D with registrable drug in secondary role abridged registration
​Special Access Routes
  • Import for re-export of unregistered devices
  • Unregistered devices for non-clinical purposes
  • Registered medical devices on consignment basis
  • Unregistered devices requested by qualified practitioners
  • Unregistered devices requested by licensed PHMC
  • Custom-made medical devices
  • Import of unregistered medical devices for exhibition
  • PSAR for Supply of Emergency Medical Devices
Registration overview
  • Registration overview
  • Application types
  • Evaluation Routes
  • Screening and evaluation stages
  • ​Application dossier
  • Retain, cancel or transfer registrations
​Registration guides for therapeutic products
  • New drug application​
  • ​Generic drug application
  • Biosimilar product application
  • Submission of Drug Master File
  • Submission of Plasma Master File
​Special Access Routes (SAR)
  • Import and supply of unregistered TP for patient's use
  • Import and supply of registered drug on consignment basis
  • Special consignment by a product registrant
  • Pandemic Special Access Route for Supply of Emergency TP
  • Special Access Route for Unauthorised COVID-19 Vaccines
​Major variation (MAV-1) application
  • Overview of MAV-1 application
  • Full evaluation route for MAV-1 application
  • Abridged evaluation route for MAV-1 application​
  • Verification evaluation route for MAV-1 application
Minor variation (MIV) application
  • Overview
  • ​Submit MIV applications
Certification of local dealers
  • Good Manufacturing Practice certificate for local manufacturers
  • Good Distribution Practice certificate for local dealers
Nitrosamine impurities in medicines
  • Nitrosamine impurities in medicines- List of medicines impacted
Certification of local dealers
  • Good Manufacturing Practice certificate for local manufacturers
  • Good Distribution Practice certificate for local dealers
Tobacco retail licence
  • Apply for a tobacco retail licence
  • Amend tobacco retail licence
  • Renew tobacco retail licence
  • Cancel tobacco retail licence
​Tobacco import and wholesale licence
  • Apply for tobacco import and wholesale licence
  • Amend tobacco import and wholesale licence
  • Renew tobacco import and wholesale licence
  • Cancel tobacco import and wholesale licence
Registration overview
  • Registration process
  • Pre-submission consultation
  • Application submission and screening
  • Evaluation and regulatory decision
  • Retain, cancel or transfer registrations
​Registration guides for Class 2 CTGTP
  • Full evaluation route
  • Abridged evaluation route
​Special Access Routes (SAR)
  • Import and supply of unregistered Class 2 CTGTP
  • Import and supply of CTGTP on consignment basis
MAV -1 application
  • Full evaluation route
  • Abridged evaluation route
Certification of local dealers
  • Good Manufacturing Practice certificate for local manufacturers
  • Good Distribution Practice certificate for local dealers
  1. Home
  2. Careers
  3. Articles
Singapore Quality Class Star
Health Sciences Authority
Who we are
Announcements
Careers
Contact us
Feedback
Report Vulnerability
Privacy Statement
Terms of Use
Sitemap
HSA Data Protection Policy
Share your views @ REACH

© 2019 Government of Singapore

Last Updated 03 Sep 2019