import, supply, storage, packaging, and advertisement of all health products in Singapore, including therapeutic products (commonly known as western pharmaceutical drugs), medical devices, and cosmetics. All pharmaceutical and medical device products must be registered with the HSA before they can be s...
Recent recalls of medical devices has increased importance of safety, awareness and regulation of the devices. Singapore and India havestrong presence and national priorities in medical devices development and use. Herein we capture the rationale of each of these national regulatory bodies and compare ...
19Advertisementofmedicaldevice 20Substantiationofassertionsofuniquenessandprominenceinadvertisements 21Advertisementof“professionaluseonly”medicaldevices 22Restrictiononadvertisementspromotingmedicaldevicesforspecifieddiseasesandconditions HEALTHPRODUCTS(MEDICALDEVICES)REGULATIONS2010 http://agcvldb.agc.gov.sg/...2010/2010...
(3) In this regulation — primary packaging , in relation to a medical device, means packaging that maintains the sterility or integrity of the medical device; secondary assembly means the process of repackaging a medical device from its original packaging into another packaging, without any breach...
Semoegy provides medical device regulations training specifically designed or relevant to the medical device industry. We provide education and knowledge.
Ordinance of the Federal Office for Safety in Health Care on the Fee tariff according to GESG; this fee regulation applies to all attachments received by the BASG from 01.07.2020. Australia (TGA) 4.European implementation of Medical Device and IVD Regulations – Implications for Australia ...
The Medical Device Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union. As more and more manufacturers now have their MDR Quality Management System (QMS) certi...
Singapore Medical Device Market Size $1.5 billion Projected Growth Rate: 11.1% Singapore Pharmaceutical Market Size $1.2 billion Projected Growth Rate: 5% Singapore Economic Statistics and Demographics GDP (PPP): $589 billion Per Capita GDP (PPP): $101,532 Real GDP Growth Rate: 3.6% Population ...
Singapore has emerged as a leading biomedical hub in Asia today for global medical device companies to conduct their research and development, manufacturing and regional headquarters activities. Through its first-of-its-kind MDRA training prog...
BSI Medical Devices provide comprehensive regulatory and market access services so medical device manufactureres can stay compliant and sell into global markets