- Product registration and change notification submissions. ���/ K��w�`�ș%���t����>��Pq ������� ~%���I&��R�#Q���q ]�ϙ�S�AJ�)�>�}�u��5���6|���4�6{g� INTRODUCTION 1.1. - Applying knowledge of Health Sciences Authority (HSA) Regulatory Guidances. Product registration applications for IVD medical devices submitted to HSA must be prepared in the format set out in the ASEAN CSDT document. - Provide regulatory support for market-released products as necessary, e.g reviewing product/manufacturing process changes for regulatory impact and documentation for changes … Introduction: The Health Sciences Authority (HSA) is a statutory board under the purview of the Ministry of Health, Singapore. GN-15-R7 Guidance on Medical Device Product Registration; GN-16-R2 Guidance on Essential Principles for Safety and Performance of Medical Devices ; GN-22-R7 Guidance for Dealers on Class A Medical Devices; GN-23-R1 Guidance on Labelling for Medical Devices; GN-30-R3 Guidance on Authorisation Route for Import on Consignment Basis; GN-33 R1.1 Guidance on the Application of … For companies working on product development, it is important to identify your product intended use and classification, as well as getting up a regulatory strategy in your early stages of design. We hereby declare that the below mentioned devices have been classified according to the classification rules and conform to the Essential Principles for Safety and Performance as laid out in the Health Products (Medical Devices) Regulations. Medical Devices Branch. - Provide regulatory … TGA needs to clearly identify the rules for abridged conformity assessment and the fees involved. Since the implementation of the Voluntary Product Registration Scheme in 2002, the HSA has had an active post-market monitoring and surveillance programme for medical devices in place. There are four evaluation routes for Class B medical devices: (i) Full Evaluation Route (ii) Abridged Evaluation Route (iii) Expedited Class B Registration (EBR) Evaluation Route (iv) Immediate Class B Registration (IBR) Evaluation Route . GN-15-R7.3: 04/2019: Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT: en : GN-17-R1: 12/2018: … This guidance document must be read in conjunction with the ASEAN CSDT document, GN-15 Guidance to Medical Device Product Registration and other relevant guidance … HSA noticed that industry stakeholders often have a confusion with the terms used across regulatory guidance documents GN-15, GN-17, GN -18 and GN-21, along with the terminologies used to refer to the types of documents needed to satisfy each requirement. Purpose This document provides guidance to assist product owners to classify medical devices using the appropriate risk-based classification rules… Workflow . GN-34 R1.3 Guidance Document for IVD Analysers(Feb-pub) 914 KB. Provide proof of compliance with reference market’s QMS requirements. ... GN-15 … Let’s take a look. Health Sciences Authority, 11 Biopolis Way #11-01, Helios, Singapore 138667 . GN-15 Annex 1 Letter of Authorisation Template 29 KB; GN-15 ANNEX 2 Marketing History Declaration Template 31 KB; GN-15 ANNEX 3 Safety Declaration Template 32 KB; IVD Analysers. If you wish to become familiar with the upcoming novelties of the HSA, we recommend you to take a look at the Draft-Guideance Documents and to forward any change requests to the HSA. No permission or authorization from the IRS is necessary to establish an HSA. T��ok��MT����0�T�Po��t*��7�r�\K�yі�H��[l`����ezV��I_]�%�%����!�(��� ��`���3���ҡ�/�є(�J�@���Ʈ�������uI�{~Hկ��!ܚY�D��1";�����V7���3*�S� ��R,�_�$�(��݌)���ߘ��bg���#;�4�F��s[A��b�B���`yǹY���}$���RdIK:W�g�8��4G���_�3A�S��� F�S��k�q�]��k0�x'v S���=@&�{-���e�U�� �� X:�yv�чf���o;���/c�Z���,2��7_w�����X�#�y4G� ����8$��t�2!�0���2�x���"�Co��^d�v?�VL��%^@� �b�Oa��!��n� Fax: +65 6478 9028. The Health Sciences Authority (HSA), its regulatory body, is an active member and contributor of the ASEAN Harmonisation Working Party (AHWP) for medical devices and the International Medical Device Regulators Forum (IMDRF). Although we have tried to ensure that the information contained here is accurate, we do not, however, warrant its accuracy or completeness. After knowing the classification of your IVD, you are now able to determine the “path” to get your product registered with HSA. Details are as follows: GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices (Revision 4.2) 1; This document provides general guidance on the medical device establishment licensing procedure. - Product registration and change notification submissions. Annex 2 to GN-3418 KB; Product Specific Regulatory guidelines… … 0�ƩO�/��Pe۟Ge��x��7���DNl���Tc8��&��!�ܽ�����Hηd�X�h�LE'���ty����� According to the act and regulations, all sterile wound care dressings in Singapore must be registered for approval before placement in the Singapore market, unless it is stated that registration is not required. * These alternate submission routes may cut as much as 50 calendar days off the review times. Excess Contributions. Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering … For more details, please refer to page 18 of GN-15: Guidance on Medical Device Product Registration, published by the Health Sciences Authority (HSA). See our information on Brexit. Applications are submitted by either fax (+65 6478 9028) or email (hsa_md_sa@hsa.gov.sg) to HSA.HSA accepts payment via GIRO only. HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 1 of 15 Registration of Class B Medical Devices ... GN-13, GN-14, GN-15, GN-17 and … These typical questions received by HSA have prompted the revision of GN-21. HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 2 of 20 PREFACE R6.1 This document is intended to provide general guidance. Clarifying the scope of the medical device regulatory framework 3. This is a simplified overview of the process. • GN-15 Guidance … The Health Sciences Authority (HSA) is a statutory board under the purview of the Ministry of Health, Singapore. The HSA recognized that different terms used for documentary requirements across the regulatory guidelines GN 15, GN 17, GN 18 and GN 21 may have caused confusion. Abridged/Expedited submission: Summary data can be submitted for pre-clinical and clinical data. Regulatory Updates Health Sciences Authority Singapore Health Details: Health, Labour and Welfare, iii) United States Food and Drug Administration, iv) Australian Therapeutic Goods Administration v) European Union Notified Bodies and the corresponding approvals indicated in GN-15.] The 2021 HSA contribution limits are higher than the 2020 amounts. You can still use HSA funds to cover Medicare expenses. More. • GN-15 Guidance on Medical Device Product Registration Class A 3. 5�{B�f:J� �]0� �v� ��U�'��m�1tX����{�[���zb�KT��o��J���V��{�N�2OpNs)�O���'�^��./gk����`�ּ��E���HH���>�v�aq%���5��R�;�}ۗ��R>����t�)�pEK��������I��2�p��$�� including but not restricted to GN-12, GN-13, GN-14, GN-15, GN-17 and GN-18. INDIA: New drugs and clinical trials rules, 2019 has been notified by government – May, 2019. GN-15-R7 Guidance on Medical Device Product Registration; GN-16-R2 Guidance on Essential Principles for Safety and Performance of Medical Devices ; GN-22-R7 Guidance for Dealers on Class A Medical Devices; GN-23-R1 Guidance on Labelling for Medical Devices; GN-30-R3 Guidance on Authorisation Route for Import on Consignment Basis; GN-33 R1.1 Guidance on the Application of … Class A and B medical devices b. Stand-alone mobile applications 2. HEALTH SCIENCES AUTHORITY ... R6.2 GN-15: Revision 6.2 (01 November 2017) R6.2 R7 GN-15: Revision 7 (01 June 2018) R7 R7.1 GN-15: Revision 7.1 (21 August 2018) R7.1 R7.2 GN-15: Revision 7.2 (08 January 2019) R7.2 R7.3 GN-15: Revision 7.3 (01 April 2019) R7.3 *Where applicable, changes and updates made in each document revision are annotated with or within the arrow symbol “ ”. Singapore medical device risk classification rules (like EU, TGA, Malaysia, etc) are drawn from the guidance by the Global Harmonization Task Force (GHTF). ��6 8�gT���A�•)����Q����WT�(��%�ZV�k�Z��Yѫ�6���� ��%����/靧��L�����ɏ9):Y.sJ����� �����N��cP����㶯S�^���E��bC��UɰfJ0 ���F�N�p �W�#� dZ%�yO���\&I]�}�cJ� ��"?������O�Mr��!��06/�W׍SY@l�g��|�Ϛ=f� Learn how HSAs work … The system consists of a total of sixteen rules. HEALTH SCIENCES AUTHORITY ... R6.2 GN-15: Revision 6.2 (01 November 2017) R6.2 R7 GN-15: Revision 7 (01 June 2018) R7 ... More information regarding the risk classification rules … The HSA frequently requests additional information after submission, which adds time to the approval process. Key Regulatory Changes 1. Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in medical devices. HEALTH SCIENCES AUTHORITY –HEALTH PRODUCTS REGULATION GROUP Page 15 of 22 medically critical status, or is preliminary and requires follow-up … The reference regulatory agency approval must be within the list of approval types listed in our GN-15 Guidance document on medical device registration to qualify for current abridged, expedited and ... HSA Telehealth Guidelines: Nov 25, 2020 medical device safety the regulation of medical devices for public health and safety by higson gr published Posted By Astrid LindgrenPublishing TEXT ID 810787fce Online PDF Ebook Epub Library MEDICAL DEVICE SAFETY THE REGULATION OF MEDICAL DEVICES FOR PUBLIC For more information regarding the requirements needed to have your IVD registered with HSA, please refer to the following guidance document - GN-15 … In Singapore, medical devices are controlled using harmonised regulatory policies and risk-based principles. It is the regulatory authority that regulates medical devices in the country according to the Health Product Act and Health Product (Medical Devices) Regulations. A Health Savings Account (HSA) is an account for individuals with high-deductible health plans to save for medical expenses that those plans do not … (GN-06, GN-10, GN-15, GN-21, GN-26, GN-27and GN-29) in every day work. Regulatory requirements for a. Health Sciences Authority Singapore Wong Woei Jiuang Ag Asst Group Director, Medical Devices Cluster, Health Sciences Authority, Singapore . In Singapore, medical devices are regulated by the Health Sciences Authority (HSA). Step 7 Appoint a registered importer to bring your device into Singapore. October 15, 2018 . For self-only coverage, you can contribute $50 more in 2021 than you could in 2020. - Provide regulatory support for market-released products as necessary, e.g reviewing product/manufacturing process changes for regulatory impact and documentation for changes … Note: Kindly see the GN-15-R7.3 Guidance on Medical Device Product Registration for more details. HSA stakeholders should take note that these updated files don’t have any regulatory changes with respect to their versions. ���-8/��qə������$ Manufacturing Site: < Physical manufacturing site(s) including sterilization site(s) > Medical Device(s): < e.g. September 2018 . Yes, you can contribute too much to your HSA. All Class A devices must be listed in the HSA’s Class A Medical Device Register by the local manufacturer or local importer. You must be an eligible individual to qualify for an HSA. endstream endobj 2527 0 obj <>stream Once you enroll in Medicare, you can no longer contribute to an HSA. It is the regulatory authority that … After knowing the classification of your IVD, you are now able to determine the “path” to get your product registered with HSA. Determine if the Medical Device is supplied in a sterile state ? The changes include: >> Faster market access for lower risk MDs; >> Clearer regulatory controls for newer MDs (e.g. ֨�\t1�lQښ�� For more information and guidance regarding product registration, please refer to the following document - GN-15 … (GN-06, GN-10, GN-15, GN-21, GN-26, GN-27and GN-29) in every day work. The Health Sciences Authority (HSA) is the regulatory authority responsible for the marketing of wound care and burn dressings in Singapore. endstream endobj 2525 0 obj <>stream A letter addressed to HSA for the request for the change of registrant from the Relinquishing Company to the Accepting Company. In order to pay by GIRO, you need to set up a CRIS account with HSA. Pre-Market Consultation and … For more information and guidance regarding product registration, please refer to the following document - GN-15-R6.1 Guidance On Medical Device Product Registration. For Singapore, the classification rules that apply under the HSA GN-13 (2014) are as follow: a) Rule 8: All implantable devices, and long-term surgically … Clement Cheong Regulatory Affairs/Quality Assurance Lead (Medical devices, Regional role) Singapore 238 connections Health Sciences Authority issued a press release announcing changes to the regulatory process for medical devices. For Singapore, the classification rules that apply under the HSA GN-13 (2014) are as follow: a) Rule 8: All implantable devices, and long-term surgically invasive devices intended to be used in direct contact with the heart. o No safety issues globally associated with the use of the medical device(s) If you wish to become familiar with the upcoming novelties of the HSA, we recommend you to take a look at the Draft-Guideance Documents and to forward any change requests to the HSA… Legal framework. The HSA recognized that different terms used for documentary requirements across the regulatory guidelines GN 15, GN 17, GN 18 and GN 21 may have caused … All forms are available on the HSA website. Product development of medical devices is subject to its own rules… Step 6 Registrant submits application electronically via the Medical Device Information and Communication System (MEDICS). WHO Western Pacific Region Clinical investigation Clinical investigation controls: Yes Details: A person may not supply a registered medical device unless samples are taken and tested, and 2524 0 obj <>stream - Product registration and change notification submissions. The Letter of Authorisation Template is found in GN-15 Guidance on Medical Device Product Registration. Table of Contents . Food Labelling – Revision of Rules on Information Provided to Consumers: Jan 15: Pilot Nutrivigilance System for Adverse Toxicological Events: Jan 8: 42 Enforcement Orders Served on Food Businesses in 2020: Jan 4: New food labelling information system for food businesses : more news Brexit Updates. Medical Devices Branch. HSA Road Rules | 2020/2021 . HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 3 of 13 PREFACE R2.1 This document is intended to provide general guidance. Pay fee. Product registration applications for IVD medical devices submitted to HSA must be prepared in the format set out in the ASEAN CSDT document. The Health Sciences Authority (HSA) accepts no liability for any errors or omissions … Free Sales Certificate and Export Certificate, Bringing personal medical devices into Singapore, COVID-19: Standards Resources for Essential Medical Devices, Bringing personal medications into Singapore, ​Controlled drugs and psychotropic substances, ​Registration guides for therapeutic products, Fees and Turnaround time of Chinese Proprietary Medicines, Good Manufacturing Practice certification for cosmetic products, Tobacco retailer educational video and quiz, Regulations for bringing in personal medications, Guidance for suppliers of hand sanitisers, Good Distribution Practice for Medical Devices, Summary Reports of Benefit-Risk Assessment, GMP conformity assessment of overseas manufacturers, Preparations allowed as General Sale List, Good Manufacturing Practice and Good Distribution Practice Standards, Handling of Applications and Conduct of Inspections During COVID-19, Renew or cancel a retail pharmacy licence, Supply of registered therapeutic products through e-pharmacy, Apply for a Chinese Proprietary Medicine dealer's licence, Amend a Chinese Proprietary Medicine dealer's licence, Good Manufacturing Practice and Good Distribution Practice, Import for re-export of Chinese Proprietary Medicines, Amend licence to wholesale or manufacture controlled drugs, Class D with a registrable drug in a secondary role full registration, Class D with registrable drug in secondary role abridged registration, Fluorescence in situ hybridisation (FISH) probes IVD, 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 PHMC, Import of unregistered medical devices for exhibition, 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, Full evaluation route for MAV-1 application, Abridged evaluation route for MAV-1 application​, Verification evaluation route for MAV-1 application, Good Manufacturing Practice certificate for local manufacturers, Good Distribution Practice certificate for local dealers, 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, GN-15-R7.3 Guidance on Medical Device Product Registration(19Apr-pub), GN-15 Annex 1 Letter of Authorisation Template, GN-15 ANNEX 2 Marketing History Declaration Template, GN-15 ANNEX 3 Safety Declaration Template, GN-34 R1.3 Guidance Document for IVD Analysers(Feb-pub), Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach, GN-17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT, E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R1.1 (20 Oct- pub), Annex 2 for GN17 and GN18 List of Configurations of Medical Devices to be Registered, GN-18 Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic (IVD) Medical Devices using the ASEAN CSDT, E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R1(pub), Annex 2 for GN17 and GN18 List of Configurations of Medical Devices (excluding IVD Clusters) to be Registered, Annex 2 for GN18 List of Configurations of IVD Clusters to be Registered, GN-13-R1.1 Guidance on the Risk Classification of General Medical Devices (Updated June 2018), GN-14-R2 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (updated on 1 June 2018), GN-12-1-R2.1 Guidance on Grouping of Medical Devices for Product Registration - General Grouping Criteria (Updated on November 2017), GN-12-2-R1.1 Guidance on Grouping of Medical Devices for Product Registration - Device Specific Grouping Criteria (Updated on November 2017), GN-23-R1.1 Guidance on Labelling for Medical Devices(20Mar-pub), GN-20-R1 Guidance on Clinical Evaluation(17dec-pub), GN-11-R1.3_Guidance on the Declaration of Conformity(18Jun-pub), GN-16-R2 Guidance on Essential Principles for Safety and Performance of Medical Devices(18Jun-pub), Annex 2 GN-16 Essential Principles Checklist Template June 2018 version, Annex 3 GN-16 Essential Principles Checklist Template Dec 2017 version, GN-02-R4.2 Guidance on Licensing of Manufacturers, Importers and Wholesalers of MD(19Apr-pub), GN-02 Annex 1 Declaration for Exemption from GDPMDS(18Aug), GN-02 Annex 3 Summary Table of Amendments, GN-02 Annex 5 Declaration of Conformity to a QMS(18Aug), GN-02 Annex 6 Declaration of Non-Dealing of Class A Medical Devices (19Apr) (2), GN-03-R3 Guidance on Preparation of a Site Master File for Licensing, SMF Example for GN-03 Guidance on Preparation of a Site Master File for Licensing, GN-22 R7.3 Guidance for Dealers on Class A Medical Devices(19 Oct-pub), GN-01-R3 Guidance on the Application of Good Distribution Practice for Medical Devices in Singapore (Updated on October 2011), GN-33 R1.2 Guidance on the Application of Singapore Standard GDPMDS(18Jul-pub), TS-01-R2.1 Good Distribution Practice for Medical Devices in Singapore - Requirements (Updated on 1 September 2012), GN-06-R2.2 Guidance on Distribution Records for Medical Devices, GN-21-R4.7 Guidance on Change Notification for Registered MD(Feb-pub), Annex 2 to GN-21 R4.7 Guidance on Change Notification for Registered MD(Feb), Annex 3 to GN-21 R4.4 Guidance on Change Notification for Registered MD(18Aug), Change Notification applications arising from the EU MDR/IVDR related changes to registered medical devices, Annex 1 to Change Notification applications arising from the EU MDR/IVDR related changes to registered medical devices, GN-24-R1.3 Guidance on the Change of Registrant(18Aug-pub), GN-24 Annex 1 Change of Registrant Application Form, GN-24 Annex 2 Relinquishing Company Declaration Form, GN-25-R1 Guidance on the Cancellation of Medical Device Listing, GN-32 R3.2_Guidance for Importation of Unregistered MD for Exhibition(18Sep-pub), FORM 32-A: Application for Importer’s Licence, Importation of Unregistered Medical Devices for Exhibition (Updated on September 2018), Form for the Export of an Unregistered Medical Device which will be Returned After its Refurbishment, Annex 2-R2.2 List of Devices (updated on 18 September 2018), List of Custom-made Medical Devices_August 2014, GN-08-R2 Guidance on Medical Device Advertisements and Sales Promotion, GN-05-R2.1 Guidance on Reporting of Adverse Events for Medical Devices, GN-10-R3.6 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2020), GN-10 Annex 1 Declaration on Completion of Correction Template (Updated on August 2018), GN-04-R2.2 Guidance on Medical Device Recall, GN-07-R2.2 Guidance on Complaint Handling of Medical Devices, GN-09-R3.5 Guidance on the Component Elements of a DHCPL(19Aug-pub), TR-01 R1.1 Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT R1.1 (20 Oct - pub), TR-02 R1 Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT(pub). 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