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
    • Active ingredients
    • Clinical trials
    • ​Controlled drugs and psychotropic substances
    • Homoeopathic medicines
    • Medicated oils, balms and medicated plasters
    • Poisons
    • Topical antiseptics
  • Risk management plan requirements
  • Report adverse events
  • International collaboration
  • Blood donation
  • Lab services
  • Who we are
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
Therapeutic products
  • Regulatory overview
  • Register your product
  • Apply for post-approval variation
  • ​Reclassify your product
  • ​Dealer's licensing and certification
  • Retain, cancel or transfer product registration
  • Risk management plan requirements
  • Report adverse events
  • Report or recall defective products
  • ​Retail pharmacy licensing
  • Clinical trials
  • Product consultation
  • Advertisements and promotions
  • ​CPP and SLS
  • Medicines quality and compliance monitoring
  • Listing of approvals and post-registration actions
  • International collaboration
  • 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
  • International collaboration
  • Fees and Turnaround time of Chinese Proprietary Medicines
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
  • Vaping enforcement
CTGTP
  • Regulatory overview
  • Class 1 CTGTP notification
  • Register a Class 2 CTGTP
  • Variation applications
  • Dealer's notice
  • ​Dealer's licensing and certification
  • Risk management plan requirements
  • Report adverse events
  • Report or recall defective products
  • Clinical trials
  • Product consultation
  • Advertisements and promotions
  • Certificate of a Pharmaceutical Product
  • Duties And Obligations
  • Guidance documents
  • Fees and turnaround time
  • Notified Class 1 CTGTP
  • Register of Class 2 CTGTP
  • Register of CTGTP Dealer's Notices, Licences and Certificates
Bringing personal medications into Singapore
  • Regulations for bringing in personal medications
  • Check medication requirements
  • Submit application for approval to bring in personal medication
Active ingredients
  • Regulatory Overview
  • Licensing and certification of importers and wholesalers
  • Licensing and certification of manufacturers
  • Certificate of a Pharmaceutical Product
  • Active ingredients used in Clinical Research/Clinical Trial
  • Guidance documents
  • Fees and turnaround time
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
COVID-19 regulatory information and consumer advisories
  • HSA's review of Swiss study
E-services
  • eGIRO
Consumer safety
  • Articles
  • Make a report
​Why join HSA
  • Apply for a job
  • Diploma in Nursing Scholarship
  • 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
  • International Medical Device Regulators Forum (IMDRF)
  • ASEAN Medical Device Committee (AMDC)
Register your product
  • Registration overview
  • ​Registration guides for therapeutic products
  • RMP submission for product registration
  • eCTD submissions 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
​Retail pharmacy licensing
  • Overview of pharmacy licence for a retail pharmacy
  • Apply for a pharmacy licence for a retail pharmacy
  • Amend a pharmacy licence for a retail pharmacy
  • Renew or cancel a pharmacy licence for a retail pharmacy
  • Compounding of therapeutic products
  • Supply of medicines via vending machine
  • 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
Medicines quality and compliance monitoring
  • Nitrosamine impurities in medicines
  • Product Quality Surveillance for therapeutic products
International collaboration
  • Access Consortium
  • Project Orbis
  • ICH
  • ICMRA
  • ASEAN Joint Assessment Procedure
  • NPRA
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 Standards
  • Certification of local dealers
  • Import for re-export of Chinese Proprietary Medicines
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
  • GMP conformity assessment of overseas manufacturers
  • RMP submission for product registration
  • ​Special Access Routes (SAR)
​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
Licensing and certification of importers and wholesalers
  • Overview of Importer's and Wholesaler's Licences
  • Apply for a licence
  • Amend a licence
  • Renew or cancel a licence
  • Good Distribution Practice Standards
  • Good Distribution Practice certification
Licensing and certification of manufacturers
  • Overview of Manufacturer's Licence
  • Apply for a Licence
  • Amend a Licence
  • Renew or cancel a licence
  • Good Manufacturing Practice Certificate
  • Inspection of Manufacturers
  • Responsibilities of Manufacturers
CTA, CTN or CTC submissions
  • New CTA or CTN submission
  • New CTC submission
  • Subsequent submissions
Conducting clinical trials
  • Principal investigator
  • 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
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 healthcare facility
  • Import of unregistered medical devices for exhibition
  • Import of unregistered pre-owned devices from maintenance/repair
  • PSAR for Supply of Emergency Medical Devices
Registration overview
  • Registration overview
  • Application types
  • Evaluation Routes
  • ​Application dossier
  • Screening and evaluation stages
  • 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
​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
  • List of impacted medicines
  • Guidance for product registrants
  • Test methods
Certification of local dealers
  • Good Manufacturing Practice certificate for local manufacturers
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 overview
  • Application submission
  • Pre-market consultation
  • Screening, evaluation and regulatory decision
  • Retain, cancel or transfer registrations
​Special Access Routes (SAR)
  • Import and supply of unregistered Class 2 CTGTP
  • Import and supply of CTGTP on consignment basis
Certification of local dealers
  • Good Manufacturing Practice certificate for local manufacturers
  • Good Distribution Practice certificate for local dealers
  1. Home
  2. Consumer safety
 
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