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    • Medical devices
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    • Tobacco regulation
    • CTGTP
  • More Regulations
    • Clinical trials
    • ​Controlled drugs and psychotropic substances
    • Poisons
    • Active ingredients
    • Homoeopathic medicines
    • Medicated oils, balms and medicated plasters
    • 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
  • Standards for Medical Devices
Therapeutic products
  • Regulatory overview
  • Register your product
  • Apply for post-approval variation
  • Listing of approvals and post-registration actions
  • ​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
  • 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
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
  • Notified Class 1 CTGTP
  • Register of Class 2 CTGTP
  • Register of Licensed CTGTP Importers, Wholesalers and Manufacturers
  • Duties And Obligations
Bringing personal medications into Singapore
  • Regulations for bringing in personal medications
  • Check medication requirements
  • Submit application for approval to bring in personal medication
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
International collaboration
  • Therapeutic products
  • Medical devices
  • Complementary health products
COVID-19 regulatory information and consumer advisories
  • HSA's review of Swiss study
E-services
  • HSA PIN
  • Infosearch
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
  • International Medical Device Regulators Forum (IMDRF)
  • ASEAN Medical Device Committee (AMDC)
Register your product
  • Registration overview
  • ​Registration guides for therapeutic products
  • 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
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 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
  • ​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
  • 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
Therapeutic products
  • Access
  • ICH
  • ICMRA
  • NPRA
  • ASEAN Joint Assessment Procedure
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 healthcare facility
  • Custom-made medical devices
  • 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
  • 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
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Last Updated 03 Sep 2019