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• Medical devices
  • Regulatory overview of medical devices
  • Medical device registration
    • Registration overview of medical devices
    • Is it a medical device
    • Risk classification of medical devices
    • Medical device risk classification tool
    • Medical device registration and licensing requirements
    • Medical device grouping tool
    • Grouping of medical devices
      • Grouping medical devices as Dental Grouping Terms (DGT)
      • Grouping medical devices as Hearing Aids
      • Grouping medical devices as Immunohistochemistry (IHC) IVDs
      • Grouping medical devices as Fluorescence In Situ Hybridization (FISH) Probes IVDs
      • Grouping medical devices as IVD analysers
      • Grouping medical devices as IVF media
      • Grouping medical devices as a Family
      • Grouping medical devices as a System
      • Grouping medical devices as a Group
      • Grouping medical devices as a Single product
      • Grouping medical devices as an IVD Test Kit
      • Grouping medical devices as an IVD Cluster
    • Registration guides
      • Register Class B medical device via full route
      • Register Class B medical device via abridged route
      • Register Class B medical device via immediate route
      • Register Class C medical device via full route
      • Register Class C medical device via abridged route
      • Register Class C medical device via expedited route
      • Register Class C medical device via immediate route
      • Register Class D medical device via full route
      • Register Class D medical device via abridged route
      • Register Class D medical device via expedited route
      • Register Class D medical device with a registrable drug in a secondary role via full route
      • Register Class D medical device with a registrable drug in a secondary role via abridged route
    • Priority Review Scheme
    • Special Access Routes (SAR)
      • Import for re-export of unregistered medical devices
      • Import and supply of unregistered medical devices for non-clinical purpose​s
      • Import of a consignment of registered medical devices
      • Import and supply of unregistered medical devices by request of qualified practitioners
      • Import and supply of unregistered medical devices at the request of a licensed healthcare facility
      • Import, manufacture or supply of custom-made medical devices
      • Import of unregistered medical devices for exhibition
      • Import of unregistered pre-owned devices returned from maintenance/repair
      • Pandemic Special Access Route (PSAR) for Supply of Emergency Medical Devices
  • Notify changes to registered medical devices
  • Importer, wholesaler and manufacturers' licensing
    • Apply for a medical device dealer's licence
    • Amend a medical device dealer's licence
    • Renew or cancel a medical device dealer's licence
    • Good Distribution Practice for Medical Devices
  • Certificates
  • Adverse events reporting of medical devices
  • Field Safety Corrective Action reporting
    • When to report
    • How to report
    • Risk management
  • Clinical trials of medical devices
  • Consultation schemes
  • Advertisements and promotions of medical devices
  • Bringing personal medical devices into Singapore
  • COVID-19: Standards Resources for Essential Medical Devices
  • Digital Health
  • International collaboration for medical devices
    • International Medical Device Regulators Forum (IMDRF)
    • ASEAN Medical Device Committee (AMDC)
  • Standards for Medical Devices
  • Guidance documents for medical devices
  • Fees and turnaround time for medical devices
• Therapeutic products
  • Regulatory overview of therapeutic products
  • Therapeutic Product Registration
    • Registration overview of therapeutic products
      • Registration overview
      • Application types
      • Evaluation Routes
      • Application Dossier
      • Application Screening and Evaluation stages
      • Retain, cancel or transfer therapeutic product registrations
    • Registration guides for therapeutic products
      • New drug application
        • Full evaluation route for new drug application
        • Abridged evaluation route for new drug application
        • Verification evaluation route for new drug application
      • ​Generic drug application
        • Abridged evaluation route for generic drug application
        • Verification or verification-CECA evaluation route for generic drug application
      • Biosimilar product application
      • Submission of Drug Master File
      • Submission of Plasma Master File
    • RMP submission for product registration
    • ECTD submissions
    • Summary Reports of Benefit-Risk Assessment
    • Special Access Routes (SAR)
      • Import and supply of unregistered therapeutic products for patient's use
      • Import and supply of registered therapeutic product on consignment basis
      • Special consignment by a product registrant
      • Pandemic Special Access Route (PSAR) for Supply of Emergency Therapeutic Products
    • Good Manufacturing Practice (GMP) conformity assessment of overseas manufacturers of therapeutic products
    • Notification of lot release information of imported vaccines for local supply
    • Pre-submission Consultation Mechanisms
  • Post-approval variation application of registered therapeutic drugs
    • Overview of variation application types
    • ​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
    • ​Major variation (MAV-2) application
    • Minor variation (MIV) application
      • Overview
      • Submit MIV applications
    • Minor variation (MIV) self-guided tool
  • Reclassification of therapeutic products
    • Apply for reclassification
    • Preparations allowed as General Sale List
    • List of reclassified medicines
  • ​Dealer's licensing and certification
    • Overview of importer, wholesaler and manufacturer's licences
    • Apply for a Therapeutic Product dealer's licence
    • Amend a Therapeutic Product dealer's licence
    • Renew or cancel a licence
    • Good Manufacturing Practice and Good Distribution Practice Standards
    • Certification of local manufacturers, importers and wholesalers
      • Good Manufacturing Practice certificate for local manufacturers
      • Good Distribution Practice certificate for local dealers
  • Retain, cancel or transfer therapeutic product registrations
  • Risk management plan (RMP) requirements
  • Adverse event reporting of therapeutic products
  • Product defect reporting and recall procedures for therapeutic products
  • 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 of therapeutic products
    • Regulatory overview of clinical trials
    • New CTA or CTN submission
    • Subsequent submissions
    • Good Clinical Practice Inspections
    • Report adverse events in clinical trials
    • Product consultation
    • Conducting clinical trials
    • Clinical Trials Register
    • Clinical trials statistics
  • Innovation Office
  • Advertisements and promotions of therapeutic products
  • Certificate of a Pharmaceutical Product and Statement of Licensing Status
    • Certificate of a Pharmaceutical Product
    • Statement of Licensing Status
  • International collaboration for therapeutic products
    • Access Consortium
    • Project Orbis
    • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
    • International Coalition of Medicines Regulatory Authorities (ICMRA)
    • ASEAN Joint Assessment Procedure for Pharmaceutical Products
    • National Pharmaceutical Regulatory Agency of Malaysia (NPRA)
  • Medicines quality and compliance monitoring
    • Nitrosamine impurities in medicines
      • List of impacted medicines
      • Guidance for product registrants on management of nitrosamine impurities in therapeutic products
      • Test methods
    • Product Quality Surveillance for therapeutic products
  • Listing of approvals and post-registration actions
  • Guidance documents for therapeutic products
  • Fees and turnaround time for therapeutic products
• Health supplements
  • Regulatory overview of health supplements
  • Voluntary Notification of Health Supplements and Traditional Medicines
  • List of Notified Health Supplements and Traditional Medicines
  • Health supplement claims
  • Advertisements and promotions of medicinal products
  • Report adverse events
  • International collaboration for complementary health products
• Traditional medicines
  • Regulatory overview of traditional medicines
  • Voluntary Notification of Health Supplements and Traditional Medicines
  • List of Notified Health Supplements and Traditional Medicines
  • Advertisements and promotions of medicinal products
  • Report adverse events
  • Traditional medicinal materials
  • International collaboration for complementary health products
• Chinese proprietary medicines
  • Regulatory overview of Chinese Proprietary Medicines
  • 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 importer, wholesaler and manufacturer's licences
    • Apply for a Chinese Proprietary Medicine dealer's licence
    • Amend a Chinese Proprietary Medicine dealer's licence
    • Renew or cancel a Chinese Proprietary Medicine dealer's licence
    • Good Manufacturing Practice and Good Distribution Practice Standards
    • Certification of local manufacturers
      • Good Manufacturing Practice certificate for local manufacturers
    • Import for re-export of Chinese Proprietary Medicines
  • Free Sale Certificate (Certificate for Exporter of Chinese Proprietary Medicines)
  • Advertisements and Promotions of Medicinal Products
  • Report adverse events
  • Traditional medicinal materials
  • International collaboration for complementary health products
  • Fees and turnaround time of Chinese Proprietary Medicines
• Cosmetic products
  • Regulatory overview of cosmetic products
  • Cosmetic product notification​
    • Submit notification and re-notification
    • Update or cancel notification
  • ASEAN Cosmetic Directive
  • Good Manufacturing Practice certification for cosmetic products
  • Report adverse events
  • Fees for cosmetic products
• Tobacco regulation
  • Overview of tobacco control
  • Tobacco licences
    • 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​
  • List of suspended and revoked tobacco licences
  • Report tobacco-related offences
  • Fees and turnaround time of tobacco licences
  • Tobacco retailer educational video and quiz
  • Vaping enforcement
• Cell, tissue and gene therapy products
  • Regulatory overview of cell, tissue or gene therapy products
  • Class 1 CTGTP notification
  • Class 2 CTGTP Registration
    • Registration of Class 2 CTGTP
      • Registration overview
      • Application submission
      • Pre-market consultation
      • Screening, evaluation and regulatory decision
      • Retain, cancel or transfer CTGTP registrations
    • Good Manufacturing Practice (GMP) conformity assessment of overseas manufacturers of CTGTP
    • RMP submission for product registration
    • Special Access Routes (SAR)
      • Import and supply of unregistered Class 2 cell, tissue or gene therapy products (CTGTP)
      • Import and supply of registered Class 2 Cell, Tissue and Gene Therapy Products (CTGTP) on consignment basis
  • Variation applications for registered CTGTP
  • Dealer's notice
  • ​Dealer's licensing and certification
    • Overview of CTGTP importer's, wholesaler's and manufacturer's licences
    • Apply for a CTGTP dealer's licence
    • Amend a CTGTP dealer's licence
    • Renew or cancel a licence
    • Good Manufacturing Practice and Good Distribution Practice Standards
    • Certification of local manufacturers, importers and wholesalers
      • Good Manufacturing Practice certificate for local manufacturers
      • Good Distribution Practice certificate for local dealers
  • Risk management plan (RMP) requirements
  • Adverse event reporting of cell, tissue or gene therapy products (CTGTP)
  • Product defect reporting and recall procedures for cell, tissue or gene therapy products (CTGTP)
  • Clinical trials of cell, tissue or gene therapy products
    • Regulatory overview of clinical trials
    • New CTA or CTN submission
    • Subsequent submissions
    • Good Clinical Practice Inspections
    • Report adverse events in clinical trials
    • Product consultation
    • Conducting clinical trials
    • Clinical Trials Register
    • Clinical trials statistics
  • Product consultation
  • Advertisements and promotions of CTGTP
  • Certificate of a Pharmaceutical Product
  • Duties And Obligations of CTGTP Registrants, Manufacturers, Importers and Suppliers
  • Guidance documents for CTGTP
  • Fees and turnaround time for CTGTP
  • Notified Class 1 Cell, Tissue or Gene Therapy Products
  • Register of Class 2 Cell, Tissue or Gene Therapy Products
  • Register of Licensed Cell, Tissue or Gene Therapy Products Importers, Wholesalers and Manufacturers
• Bringing personal medications into Singapore
  • Regulations for bringing personal medications into Singapore
  • Check requirements for bringing personal medications into Singapore
  • Submit application for approval to bring in personal medications
• Active ingredients
  • Regulatory overview of active ingredients
  • Licensing and Certification of Importers and Wholesalers
    • Overview of Importer's and Wholesaler's Licences
    • Apply for active ingredient importer's and wholesaler's licence
    • Amend an active ingredient importer’s or wholesaler’s licence
    • Renew or cancel active ingredient importer's and wholesaler's licence
    • Good Distribution Practice Standards
    • Good Distribution Practice Certification
  • Licensing and Certification of Manufacturers
    • Overview of manufacturer's licence
    • Apply for an active ingredient manufacturer's licence
    • Amend an active ingredient manufacturer's licence
    • Renew or cancel an active ingredient manufacturer’s licence
    • Good Manufacturing Practice Certificate
    • Inspection of Manufacturers
    • Responsibilities of Manufacturers
  • Certificate of a Pharmaceutical Product
  • Requirements for Active Ingredients Notification
  • Guidance documents for active ingredients
  • Fees and turnaround time for active ingredients
• Clinical trials
  • Regulatory overview of clinical trials
  • CTA, CTN or CTC submissions
    • New Clinical Trial Authorisation (CTA) or Clinical Trial Notification (CTN) submission
    • New Clinical Trial Certificate (CTC) submission
    • Subsequent submissions
  • Submit a Clinical Research Materials notification
  • Good Clinical Practice Inspections
  • Adverse events reporting in clinical trials
  • Innovation Office
  • Conducting clinical trials
    • Principal Investigator
    • ​Sponsor
    • ​Informed consent
    • ​Investigational and auxiliary products
    • ​Investigator Site File
    • ​Template forms
  • Participating in clinical trials
  • Guidance documents for clinical trials
  • Clinical Trials Register
  • Clinical trials statistics
• Controlled drugs and psychotropic substances
  • Controlled drugs
    • Apply for a controlled drugs licence
    • Amend licence to wholesale or manufacture controlled drugs
    • Renew or cancel a licence
  • Psychotropic substances
  • Restricted substances
  • Fees and turnaround time of controlled drugs and psychotropic substances
• Homoeopathic medicines
• Medicated oils, balms and medicated plasters
• Poisons
  • Overview of Form A Poisons Licence
  • Apply for a Form A Poisons Licence
  • Amend Form A Poisons Licence
  • Renew or cancel a licence
  • Fees and turnaround time of poisons
• Topical antiseptics
  • Regulatory overview of topical antiseptics
  • Topical antiseptics classification guide
• Risk management plan (RMP)
  • Overview on RMP
  • RMP submission for product registration
  • Post-registration RMP obligations
• Report adverse events
• Advertisements and Promotions of Medicinal Products
• International collaboration
  • International collaboration for therapeutic products
    • Access Consortium
    • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
    • International Coalition of Medicines Regulatory Authorities (ICMRA)
    • National Pharmaceutical Regulatory Agency of Malaysia (NPRA)
    • ASEAN Joint Assessment Procedure for Pharmaceutical Products
  • International collaboration for medical devices
    • International Medical Device Regulators Forum (IMDRF)
    • ASEAN Medical Device Committee (AMDC)
  • International collaboration for complementary health products
    • Access Consortium
    • ASEAN Harmonisation of Traditional Medicines and Health Supplements
• HSA's Regulatory Information and Consumer Advisories on COVID-19
  • HSA’s review of Swiss study that reported heart injury associated with COVID-19 mRNA vaccine
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  • Blood facts and figures
    • Misconceptions about blood donation
  • Blood transfusion
    • Blood transfusion process
      • ​Before blood transfusion
      • ​During blood transfusion
    • Blood transfusion risks
    • Autologous Donation
  • COVID-19 VACCINE
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