HSA - Singapore Health Science Authority. This … If you are trying to reduce costs and waste and streamline your … The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Singapore Government.Its office is located next to Outram Park MRT station.. On 1 April 2019, HSA's food related duties were absorbed by its successor Singapore Food Agency (SFA) which also absorbed the food related duties of two other statutory boards namely Agri-Food and … Our team developed and completed new skin care formula in Singapore and obtained HSA certification. Browse... Attachment(s): Up to 10 files … Health Sciences Authority HSA Import Declaration of Health Products. The proposed amendments intend to further improve the regulatory framework to facilitate access and innovation while safeguarding consumer health and safety. These include: Items we find in our bathroom cabinets such as toothpastes, bath products, shower gels, shampoos, conditioners and shaving creams; Products on our dressers such as make-up items, skin whitening, anti-wrinkle creams and perfumes/fragrances ; … Manufacturing continuous improvement Lean Manufacturing, Six Sigma. There were over 4000 medical devices that were approved back then. In addition to Health Sciences Authority (HSA) certification, registration and licensed distribution requirements, the supply and use of medical devices in Singapore may be subject to additional regulations, such as the provisions of the Private Hospitals and Medical Clinics Act, and the Radiation Protection Act. Requirements can differ depending on the type of medical device … Focal Point Network; European Healthy Workplaces Campaign 2020-2022; European Healthy Workplaces Campaign 2018-2019 The Singapore Food Agency (SFA) is the lead agency for food-related matters; IT/ E-Services Call 67760168 for IT technical help from 7am to midnight daily or email helpdesk@hsahelp.gov.sg; Other Feedback Case Classification * (success) Required field. The dealers are expected to transition to these accredited CBs. Does HSA regulate surgical masks from overseas manufacturers? Our product has no preservatives, additives & microorganisms and it has been recognized by ten countries in ASEAN. Message * (success) Required field. Singapore’s chief medical regulatory body is the Health Sciences Authority (HSA).In 2007, the HSA passed the Health Products Act, allowing them to conduct mandatory product registration and regulate the supply, distribution, manufacturing, import, and advertisement of all health products.Registered medical devices are listed on the Singapore Medical Device Register … Singapore authorities will not accept ignorance as an excuse for not … The Health Sciences Authority (HSA) has assessed that the Pfizer-BioNTech and Moderna COVID-19 Vaccines meet safety and efficacy standards. HSA introduced the Dossier Clarification Supplement in April 2018 for chemical NDA and GDA to facilitate applicants to leverage the approval from a reference agency for the regulatory filing to HSA through the submission of supplementary information, as well as confirmation of the CMC aspects of a therapeutic product for which regulatory approval is sought in Singapore are the … September 2018 . HSA conducted a webinar last March 2, 2021 discussing the future of ISO 13485 Certification for Medical Device Dealers in Singapore. Type * (success) Required field. The company must also hold valid Good Distribution Practice for Medical Devices (GDPMDS) certification that has been performed by accredited certification bodies listed with the Singapore Accreditation Council or an ISO 13485 certificate that specifies storage and distribution of the categories of medical devices concerned and the activities performed at the facility Clarifying the scope of the medical device regulatory framework 3. In Singapore, medical devices are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). LICENSE VALIDITY: 1 Year – The license will be automatically renewed for another year after the annual renewal fee is paid. Fire Detection and Warning; Emergency Escape and Fire Fighting; Fire Prevention; First … A series of proposed changes to the Health Product (Medical Device) Regulations 2010 have been announced by the Health Sciences Authority (HSA), Singapore. The announcement came during an industry briefing held on October 19, in which the HSA outlined the reasons for the system and its basic features, going on to discuss plans for its phased implementation. The Health Science Authority or HSA is the Singaporean regulatory agency for health products. LICENSE TRANSFER: License transfer process is possible in Singapore, the process is called “Change of … More than 99% of all imports into Singapore enter the country duty-free. Testing, Inspection, Certification (TIC) Aviation & Aerospace Construction & Built Environment Digital / ICT Electrical & Electronics Engineering Energy & Chemicals Environment & Sustainability Food Manufacturing & Services Healthcare & Biomedical Engineering Land Transport Logistics Marine & Offshore Engineering Precision Engineering & Industry 4.0 Retail / Wholesale Trade Singapore is a member of the Association of Southeast Asian Nations (ASEAN). If the body is referred to the Mortuary at HSA by the police (where you are unable to contact a doctor or the doctor is unable to certify the cause of death), the death will be registered there. For dutiable goods, the taxable … Majority of surgical masks for local use were being imported from overseas. You must verify the particulars on the Death Certificate, then sign the Death Certificate. Medical devices with prior authorization in the US, Europe, Canada, Australia, or Japan are eligible for abridged … In Singapore, the Health Sciences Authority (HSA) oversees the safety issues linked to cosmetic products. If you are about to be audited by the Singaporean HSA or have already been, ... Training for the pharmaceutical, medical device & veterinary industries. Health Products Act requires that the product owner and its registrant must register the product with HSA in order to be listed in the Singapore Medical Device Register (SDMR). For social and/or environmental reasons, Singapore levies high excise taxes on distilled spirits and wine, tobacco products, motor vehicles and petroleum products. Key Regulatory Changes 1. The Health Products Regulation Group ensures that medical devices are wisely regulated and meet safety, quality, and efficacy standards. In addition to Health Sciences Authority (HSA) certification, registration and licensed distribution requirements, the supply and use of medical devices in Singapore may be subject to additional regulations, such as the provisions of the Private Hospitals and Medical Clinics Act, and the Radiation Protection Act. The main components of essential oil series skin care … The Medical Devices Branch of Singapore’s Health Sciences Authority (HSA) has announced, in a webinar held on March 2, that it intends to only issue dealer licenses to companies that can provide either 1) a Medical Device Single Audit Program (MDSAP) certificate, or 2) an ISO 13485 certificate from a third-party certification body (CB) accredited by the Singapore Accreditation … The HSA’s vision is to be the leading innovative authority protecting and advancing national health and safety. Overhead Power Lines; Underground Cables ; Information Guidance Legislation. Press Releases 2021; Contacting the HSA during the COVID-19 crisis; Media Queries; News and Articles; Newsletters & Bulletins; European Agency for Safety and Health at Work. ET These regulations dictate how medical devices are classified in Singapore … Such clinical trials require a Clinical Trial Certificate (CTC) issued by HSA before the trial can be conducted; The sponsor should be a locally registered business entity registered with the Accounting and Corporate Regulatory Authority (ACRA) in Singapore. The Health Sciences Authority (HSA) was a statutory board of the Singapore Ministry of Health. It was formed on April 1st, 2001 by integrating five specialized Ministry of Health agencies: the Centre for … It is responsible for securing the national blood supply and providing scientific guidance on forensic science and medicine. Am Med International Pte Ltd is the authorised exporter of Surgical Masks, face shield and Medical Supplies for Fabri-Tech, a Singapore based manufacturer. REGULATORY AUTHORITY: Health Sciences Authority (HSA) CLASSIFICATION SYSTEM: ... (GDPMD) certification (other than Class A devices). Singapore’s Health Sciences Authority (HSA) … Singapore is generally a free port and an open economy. HSA Events; HSA Webinars. Lonza's facility joins leading CMOs as one of the first Cell Therapy manufacturing facilities in Singapore to receive certification from the Singapore Health... | May 7, 2021 The webinar shares plans of accreditation of CBs that certifies local medical device dealers. Singapore’s Health Sciences Authority (HSA) has announced that it will introduce a Unique Device Identification (UDI) system to be used for medical devices. For the following health products that are subject to HSA’s licensing and/or approval requirements before importation, an importer or dealer is required to submit import declarations using applicable HSA Product Codes and furnish the relevant licence and/or approval information: Singapore is a member of the Association of Southeast Asian Nations (ASEAN) and its regulatory system is based on the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010. Video - Dangers from Power Lines on Farms; Role of the Commission for Regulation of Utilities; HSA & Other Organisations; Employees Duties; Explosives; Fire. We supply 100% pure plant essential oil. Company News; Industrial News; At the beginning of the epidemic, Foregene paid close attention to it, and organized scientific research immediately to invest in the R&D of new coronavirus nucleic acid detection kits. Upon full implementation, ISO13485 from accredited CBs will be accepted for … The Health Sciences Authority (HSA) was formed since 2001 when the voluntary registration was introduced. Companies that fail to accurately report adverse incidents could face severe financial penalties or, in extreme cases, criminal charges. The sponsor should … Which vaccines are approved for use in Singapore? In an effort to provide such assurance, organizations will require more than a few quality manuals. MADE IN SINGAPORE Our masks are made in Singapore in a HSA Audited clean controlled environment , certified and approved by HSA, Licence No: ES0500981 & TÜV. Certification against GDPMDS qualifies that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification. The registration pathway of medical devices depends of their classification. Class A and B medical devices b. Stand-alone mobile applications 2. HSA has authorised their use locally under the Pandemic Special Access Route (PSAR) which facilitates early access to vaccines and medicines during a pandemic, … Requirements can differ depending on the type of medical device … Health Products (Medical Devices) Regulation was implemented in August 2011 and all medical devices have to be approved by the Medical Device Branch of HSA before it can be supplied in Singapore. In January 2020, our products passed the HSA approval. We offer class room training or on line GMP training anywhere in the world. Webinar Recordings; News. SDMR listing must occur before the device is to be supplied to the local market. Works Needing Certification; Powerlines and Cables. In January 2020, during the early phase of the COVID-19 pandemic, there was only one licensed local manufacturing facility for surgical masks in Singapore. Singapore's Health Sciences Authority (HSA) requires medical device manufacturers to comply with a vigilance system for post-market monitoring and adverse event reporting. Medical devices in Singapore are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). Health Sciences Authority Singapore Wong Woei Jiuang Ag Asst Group Director, Medical Devices Cluster, Health Sciences Authority, Singapore . Files To Upload. Press Release Singapore Health Sciences Authority (HSA) Approves Interim Authorization of COVID-19 Vaccine Moderna For Use Published: Feb. 3, 2021 at 11:04 p.m. The product registration requirement would only be applicable to Class A sterile, Class B, Class C and Class D medical … Foregene Covid-19 Nucleic Acid Detection Kit passed EU CE and Singapore HSA certification. Regulatory requirements for a. Based on years of accumulated technical precipitation … News. Singapore levies a 7% Goods and Services Tax (GST). Pre-Market Consultation …
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