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Medical devices

Regulatory overview
Register your device
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Dealer's licence
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Bringing personal medical devices into Singapore
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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
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Retail pharmacy licensing
Clinical trials
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International collaboration
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Health supplements

Regulatory overview
Voluntary Notification of HS and TM
List of Notified HS and TM
Health supplement claims
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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
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Clinical trials
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Fees and turnaround time
Notified Class 1 CTGTP
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Register of Licensed CTGTP Importers, Wholesalers and Manufacturers

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
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Report adverse events
Innovation Office
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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
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Fees and turnaround time

Topical antiseptics

Regulatory overview
Topical antiseptics classification guide

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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

International collaboration

Access Consortium
Project Orbis
ICH
ICMRA
ASEAN Joint Assessment Procedure
NPRA

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
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
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
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

Home
Medical devices
Medical device registration

Medical device grouping tool

Check if you can group your medical devices for registration.

Before you begin:

You will need to determine your medical device’s risk classification.
If you wish to register each medical device as a single product, please proceed to check your registration and licensing requirements before registration.
If you are unsure which grouping is most appropriate for your medical devices, please proceed with our assessment below.

Last updated: 31 Dec 2018

Medical devices

Regulatory overview
Register your device
Changes to registered devices
Dealer's licence
Free Sale 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
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
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