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RECALL OF HAND SANITISERS (FEB TO APRIL 2021) Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. Date of Recall: Feb to Apr 2021. Products: Asepsoâ„¢ Professional Hand Sanitiser (Batch: B42M) Cuticura Hand Sanitizer (all batches) Epi KleenGel Hand Sanitizer Gel (all batches) HSA | COSMETIC PRODUCT NOTIFICATION Submit notification and re-notification Find out how to submit a cosmetic product notification before you sell your cosmetic product in Singapore. Update or cancel notification Find out how to update or cancel a notification after it has already been submitted. Last updated: 25 Sep 2019. HSA | GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES Good Distribution Practice for Medical Devices. Dealers must have a Quality Management System that meets requirements to ensure the safety, quality and performance of medical devices they are dealing in. Importers and wholesalers dealing with medical devices in Singapore should develop a Quality Management System (QMS) thatconforms to the
HSA | RISK CLASSIFICATION OF MEDICAL DEVICESSEE MORE ON HSA.GOV.SG GUIDE TO SUBMISSION OF UPDATE TO CLASS A MEDICAL … GUIDE TO SUBMISSION OF UPDATE TO CLASS A MEDICAL DEVICE EXEMPTION LIST Last update: August 2018 Page 5 of 6 Note 1. The excel file cannot contain any blank cells within the columns B – columns J and shouldnot
HEALTH SCIENCES AUTHORITY (HSA)E-SERVICESREPORT ADVERSE EVENTSBLOOD DONATIONLAB SERVICESWHO WE ARE HSA is the national authority regulating health products; managing the national blood bank, transfusion medicine and forensic medicine expertise; and providing HSA | INFOSEARCH FOR HEALTH PRODUCTS AND SERVICES Illegal health products found in Singapore. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for assistance. Last updated: 19 Apr 2021. Content in this section show. E-services. Infosearch. HSA | MEDICAL DEVICE INFORMATION COMMUNICATION SYSTEM (MEDICS) E-services. Ensure you have the following credentials before you access the MEDICS e-service: CRIS company account. CorpPass. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for assistance. apply@medics. apply@medics. E-services. HSA | SPECIAL ACCESS ROUTES Special Access Routes (SAR) In specific situations, we may allow the import or the supply of therapeutic products via Special Access Routes (SAR). Import and supply of unregistered TP for patient's use Hospitals or clinics need approval from us before importing unregistered therapeutic products for HSA | REGISTRATION OVERVIEW OF MEDICAL DEVICES Class B, C and D registration. Refer to the table below for an overview of the evaluation routes for Class B, C and D medical devices. A medical device without prior approval from any of our overseas reference regulatory agencies must undergo a full evaluation. The following medical devices cannot take the expedited Class C (ECR)route.
RECALL OF HAND SANITISERS (FEB TO APRIL 2021) Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. Date of Recall: Feb to Apr 2021. Products: Asepsoâ„¢ Professional Hand Sanitiser (Batch: B42M) Cuticura Hand Sanitizer (all batches) Epi KleenGel Hand Sanitizer Gel (all batches)HSA | E-SERVICES
Update changes to your business or company information such as company name, company address, contact details and other related information. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for HSA | GUIDANCE DOCUMENTS FOR THERAPEUTIC PRODUCTS Guidance documents for therapeutic products. Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products. 8. Guideline on the Registration of Human Plasma-derived TherapeuticProducts 79 KB. 9.
HSA | GUIDANCE DOCUMENTS FOR CLINICAL TRIALS Clinical trial submissions Clinical trial submissions . Guidance on determination of whether a clinical trial requires a Clinical Trial Authorisation, Clinical Trial Notification or Clinical Trial Certificate 498 KB (updated 1 Mar 2021); Guidance on regulatory requirements for new applications and subsequent submissions 452 KB (updated 28 Apr 2021) HSA GRANTS PROVISIONAL AUTHORISATION FOR ‘BREFENCE … hsa grants provisional authorisation for ‘brefence go covid-19 breath test system’ and ‘traciex breathalyser’ for detection ofcovid-19 infection
SPECIAL ACCESS ROUTE FOR UNAUTHORISED COVID-19 VACCINES This Special Access Route (SAR) applies only to COVID-19 vaccines that are granted Emergency Use List (EUL) by the World Health Organization (WHO) and have not been authorised under the Pandemic Special Access Route (PSAR) by HSA, i.e. non-PSAR authorised vaccines. GUIDANCE ON THE IMPORT OF HAND SANITISERS, MASKS Guidance on the Import of Hand Sanitisers, Masks, Thermometers and Protective Gear. Hand Sanitisers Hand sanitisers do NOT need approval from the Health Sciences Authority (HSA) before they are brought intoSingapore for sale.
COVID-19 ANTIGEN RAPID TESTS (ART) SELF-TEST KITS The Health Sciences Authority (HSA) is committed to ensuring the availability of COVID-19 antigen rapid test (ART) self-test kits that meet the required safety, efficacy and quality standards, for individuals to administer on their own. HSA GRANTS INTERIM AUTHORISATION FOR FOUR COVID-19 ANTIGEN Name of antigen rapid test self-test kit. Name of distributor. Authorisation date. Abbott PanBio TM COVID-19 Antigen Self-Test. Unison Collaborative Pte Ltd. 31 May 2021. Quidel QuickVue At-Home OTCCOVID-19 Test
HSA | IMPORTER, WHOLESALER AND MANUFACTURERS' LICENSING Apply for a licence You need to use MEDICS to apply for a dealer's licence. This includes the manufacturer, importer and wholesaler's licences. Amend a licence You must notify us of changes to your dealer's licence on details such as medical device risk classification, QMS certification and company details. Renew or cancel a licence Renew your dealer's licence on time to continue dealing in HSA UNCOVERS ILLEGAL SURGICAL MASK MANUFACTURING AND HSA Uncovers Illegal Surgical Mask Manufacturing and Repackaging Facility, Consumers Advised to Stop Using Masks from Vision EmpireHealthcare
HSA | E-SERVICES
Update changes to your business or company information such as company name, company address, contact details and other related information. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for HSA | INFOSEARCH FOR HEALTH PRODUCTS AND SERVICES Illegal health products found in Singapore. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for assistance. Last updated: 19 Apr 2021. Content in this section show. E-services. Infosearch. HSA | MEDICAL DEVICE INFORMATION COMMUNICATION SYSTEM (MEDICS) E-services. Ensure you have the following credentials before you access the MEDICS e-service: CRIS company account. CorpPass. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for assistance. apply@medics. apply@medics. E-services. RECALL OF HAND SANITISERS (FEB TO APRIL 2021) Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. Date of Recall: Feb to Apr 2021. Products: Asepsoâ„¢ Professional Hand Sanitiser (Batch: B42M) Cuticura Hand Sanitizer (all batches) Epi KleenGel Hand Sanitizer Gel (all batches) HSA | GUIDANCE DOCUMENTS FOR CTGTP Guidance documents for CTGTP. Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in cell, tissue or gene therapy products. Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products 408 KB. HSA | REGULATORY OVERVIEW OF CELL, TISSUE OR GENE THERAPY Legislation. We regulate therapeutic products in Singapore under the Health Products Act (HPA) and its regulations, including the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021. minimally manipulated, i.e. biological characteristics or functions of the cell or the structural properties of the tissue are not altered. HSA | IMPORTER, WHOLESALER AND MANUFACTURERS' LICENSING Apply for a licence You need to use MEDICS to apply for a dealer's licence. This includes the manufacturer, importer and wholesaler's licences. Amend a licence You must notify us of changes to your dealer's licence on details such as medical device risk classification, QMS certification and company details. Renew or cancel a licence Renew your dealer's licence on time to continue dealing in HSA | IMPORT AND SUPPLY OF UNREGISTERED THERAPEUTICSEE MORE ONHSA.GOV.SG
HSA | OVERVIEW OF VARIATION APPLICATION TYPES There are two types of variation applications of existing registered therapeutic products: Major variation application (MAV) Minor variation application (MIV) Application type. Conditions. MAV-1. Any variation to the approved indication, dosing regimen or patient group (s). Inclusion of clinical information extending the usage of theproduct
HSA | GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES Good Distribution Practice for Medical Devices. Dealers must have a Quality Management System that meets requirements to ensure the safety, quality and performance of medical devices they are dealing in. Importers and wholesalers dealing with medical devices in Singapore should develop a Quality Management System (QMS) thatconforms to the
HSA | E-SERVICES
Update changes to your business or company information such as company name, company address, contact details and other related information. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for HSA | INFOSEARCH FOR HEALTH PRODUCTS AND SERVICES Illegal health products found in Singapore. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for assistance. Last updated: 19 Apr 2021. Content in this section show. E-services. Infosearch. HSA | MEDICAL DEVICE INFORMATION COMMUNICATION SYSTEM (MEDICS) E-services. Ensure you have the following credentials before you access the MEDICS e-service: CRIS company account. CorpPass. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for assistance. apply@medics. apply@medics. E-services. RECALL OF HAND SANITISERS (FEB TO APRIL 2021) Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopeia limit. Date of Recall: Feb to Apr 2021. Products: Asepsoâ„¢ Professional Hand Sanitiser (Batch: B42M) Cuticura Hand Sanitizer (all batches) Epi KleenGel Hand Sanitizer Gel (all batches) HSA | GUIDANCE DOCUMENTS FOR CTGTP Guidance documents for CTGTP. Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in cell, tissue or gene therapy products. Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products 408 KB. HSA | REGULATORY OVERVIEW OF CELL, TISSUE OR GENE THERAPY Legislation. We regulate therapeutic products in Singapore under the Health Products Act (HPA) and its regulations, including the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021. minimally manipulated, i.e. biological characteristics or functions of the cell or the structural properties of the tissue are not altered. HSA | IMPORTER, WHOLESALER AND MANUFACTURERS' LICENSING Apply for a licence You need to use MEDICS to apply for a dealer's licence. This includes the manufacturer, importer and wholesaler's licences. Amend a licence You must notify us of changes to your dealer's licence on details such as medical device risk classification, QMS certification and company details. Renew or cancel a licence Renew your dealer's licence on time to continue dealing in HSA | IMPORT AND SUPPLY OF UNREGISTERED THERAPEUTICSEE MORE ONHSA.GOV.SG
HSA | OVERVIEW OF VARIATION APPLICATION TYPES There are two types of variation applications of existing registered therapeutic products: Major variation application (MAV) Minor variation application (MIV) Application type. Conditions. MAV-1. Any variation to the approved indication, dosing regimen or patient group (s). Inclusion of clinical information extending the usage of theproduct
HSA | GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES Good Distribution Practice for Medical Devices. Dealers must have a Quality Management System that meets requirements to ensure the safety, quality and performance of medical devices they are dealing in. Importers and wholesalers dealing with medical devices in Singapore should develop a Quality Management System (QMS) thatconforms to the
HEALTH SCIENCES AUTHORITY (HSA) HSA is the national authority regulating health products; managing the national blood bank, transfusion medicine and forensic medicine expertise; and providingHSA | E-SERVICES
Update changes to your business or company information such as company name, company address, contact details and other related information. If you encounter technical issues for the e-services, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily) for HSA'S PANDEMIC SPECIAL ACCESS ROUTE Facilitates Singapore's access to critical novel vaccines, medicines and medical devices. The Health Sciences Authority (HSA) has introduced a Pandemic Special Access Route (PSAR) to facilitate early access to critical novel vaccines, medicines and medical devices during a pandemic, such as the current COVID-19 pandemic. HSA REMOVES OVER 700 LISTINGS OF ILLEGAL HEALTH PRODUCTS HSA Removes Over 700 Listings of Illegal Health Products from Local E-Commerce Platforms During Week of Global Intensified Surveillance. The Health Sciences Authority (HSA) has removed more than 3,200 product listings from local e-commerce platforms from January to May2021.
NEW INITIATIVES FOR REGISTRATION OF THERAPEUTIC PRODUCTS New Initiatives for Registration of Therapeutic Products 14 May 2021. Enhanced Dossier Clarification Supplement on Chemistry, Manufacturing & Controls (CMC) for New Drug Applications and Generic DrugApplications
HSA | GUIDANCE DOCUMENTS FOR CTGTP Guidance documents for CTGTP. Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in cell, tissue or gene therapy products. Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products 408 KB. HSA | MEDICAL DEVICE REGISTRATION Registration overview Understand the evaluation routes, fees and turn-around-times applicable when you register your medical device. Is it a medical device Tool Check if your device is considered a medical device in Singapore. Risk classification rules and factors Understand the general risk classification system for medical devices, as well as the rules and factors that determine risk class. HSA | IMPORTER, WHOLESALER AND MANUFACTURERS' LICENSING Apply for a licence You need to use MEDICS to apply for a dealer's licence. This includes the manufacturer, importer and wholesaler's licences. Amend a licence You must notify us of changes to your dealer's licence on details such as medical device risk classification, QMS certification and company details. Renew or cancel a licence Renew your dealer's licence on time to continue dealing in NEW POST-APPROVAL INITIATIVES FOR THERAPEUTIC PRODUCTS New post-approval initiatives for therapeutic products. The Therapeutic Products Branch (TPB), Health Products Regulation Group, is pleased to share the following new post-approval initiatives. HSA | GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES Good Distribution Practice for Medical Devices. Dealers must have a Quality Management System that meets requirements to ensure the safety, quality and performance of medical devices they are dealing in. Importers and wholesalers dealing with medical devices in Singapore should develop a Quality Management System (QMS) thatconforms to the
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We serve the administration of justice with the use of forensic medicine, forensic science and analytical chemistry testing.Blood services
We secure the nation's blood supply by ensuring a safe and adequate blood supply for public and private hospitals. Health products regulation We regulate health products to meet standards of safety, quality andefficacy.
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