新加坡医疗器械注册 Medical Devices Register in Singapore 所在地 光明区邦凯科技园 联系电话 13929216670 手机 13929216670 项目经理 cassiel 请说明来自顺企网,优惠更多 请卖家联系我 产品详细介绍 To register a medical device inSingapore, you need to follow the registration process outlined bythe Health Scien...
DeviceRegisterbythelocal manufacturerorlocalimporter. Forsystems,productfamiliesorothermulti-componentdevices,determineyourmost favorable grouping strategyaccordingtoHSAGuidanceGN-12. AppointaSingaporeRegistranttocoordinateandsubmityourdeviceregistrationapplicationtotheHSA. ...
Are Software-Based Devices Subject To The Same Korea Medical Device Registration Process As Hardware Devices? a Are Stability Studies Needed For Registering Medical Devices In Korea? a Are There Accelerated Pathways for Drug Registration in Singapore? a Are There Additional Fees Associated Wit...
For more information about Singapore’s medical device registration process, please see Medical Device Registration in Singapore. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge Medical (www.pacificbridgemed...
medical device” means a medical device that is to be used on an individual solely by, or under the supervision of, a qualified practitioner; qualified practitioner means — (a) a registered medical practitioner under the Medical Registration Act (Cap. 174), when acting in the course of provi...
Singapore requires foreign medical device manufacturers with no presence in the country to appoint an in-country regulatory representative (Registrant) to manage their product registrations. Your registrant is critical to your device registration and suc
ARQon is a medical device consultant for Regulatory, Quality RA/QA, device registration, clinical trials, ISO13485, GDPMD, MDSAP and distribution consulting.
ARQon is a medical device consultant for Regulatory, Quality RA/QA, device registration, clinical trials, ISO13485, GDPMD, MDSAP and distribution consulting.
Before exporting a medical device from Singapore, it must be registered on the Singapore Medical Device Register (SMDR). The registration process involves submitting comprehensive information about the device, including its intended use, design, manufacturing process, and clinical evidence. Once registered...
Asia Actualwith questions or a request for support in Thailand. Asia Actual has a fully licensed offices in Bangkok staffed by experienced, bi-lingual regulatory and commercial professionals to offer medical device registration, independent license holding, importing and sales support services in ...