Responsible for the regulation of medical devices, drugs, national blood bank, and healthcare services ▫ www hsa gov sg Centre for Medical Device Regulation
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[PDF] Singapore - WHO World Health Organization
html For the registration of a medical device, it is required that it is: safe to use, of suitable quality as to its specifications, manufacture, and measures taken to ensure that quality, effective for its intended purpose Health Products Act (Medical Devices) Regulations, 25
[PDF] Regulatory Guidelines for Software Medical Devices - Health
submitted for device registration in Singapore 298 299 The essential design and manufacturing principles that may be relevant to software medical devices
[PDF] MEDICAL DEVICE GUIDANCE - Health Sciences Authority
3 avr 2019 · GN-15: Guidance on Medical Device Product Registration Revision 7 3 supplying the health product by export to a party outside Singapore
[PDF] Medical Devices - Baker McKenzie
Singapore Medical Devices In August 2010, Singapore implemented the Health Products (Medical Devices) Regulations 2010, pursuant to the Health
[PDF] Regulatory Updates on Singapore Medical Device Market
Responsible for the regulation of medical devices, drugs, national blood bank, and healthcare services ▫ www hsa gov sg Centre for Medical Device Regulation
[PDF] HEALTH PRODUCTS (MEDICAL DEVICES) REGULATIONS 2010
certificate of origin certifying that the medical device is manufactured in Singapore and registered under the Act (3) An application for a certificate under
[PDF] HSA Circular to Exhibitors and Importers
In Singapore, medical devices are subject to regulation under the Health Products Act Under this law, the import and supply of all medical devices, including in
[PDF] COVID-19 Medical Devices: Singapore - Bird & Bird
Due to the COVID-19 pandemic, many countries have enacted emergency legislation removing certain regulatory barriers and exempting products from
[PDF] MEDICAL DEVICE GUIDANCE - Globi-Reg
Medical Device Branch Health Products Regulation Group Health Sciences Authority 11 Biopolis Way #11-01 Helios Singapore 138667 Fax: (65) 6478 9028
[PDF] ASEAN Agreement on Medical Device Directive - ASEAN Legal
Singapore, the Kingdom of Thailand and the Socialist Republic of Viet Nam, Member Medical Device Directive (hereinafter referred to as “Agreement") and its
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