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Good Distribution Practice for Medical Device in Singapore. Companies that are involved in wholesaling and/or importing Medical Devices in Singapore are required to pass the GDPMDS certification audit prior to applying for Importer or Wholesaler’s Licence . In order to be certified by the certification bodies, companies are required to have implemented a quality management system that adheres to current good distribution practices. Companies are encourage to get certified early and apply for their licenc...

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Good Distribution Practice for Medical Device in Singapore. Companies that are involved in wholesaling and/or importing Medical Devices in Singapore are required to pass the GDPMDS certification audit prior to applying for Importer or Wholesaler’s Licence . In order to be certified by the certification bodies, companies are required to have implemented a quality management system that adheres to current good distribution practices. Companies are encourage to get certified early and apply for their licenc...

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GDPMDS Home | gdpmds.com Reviews

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Good Distribution Practice for Medical Device in Singapore. Companies that are involved in wholesaling and/or importing Medical Devices in Singapore are required to pass the GDPMDS certification audit prior to applying for Importer or Wholesaler’s Licence . In order to be certified by the certification bodies, companies are required to have implemented a quality management system that adheres to current good distribution practices. Companies are encourage to get certified early and apply for their licenc...

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Good Distribution Practice for Medical Device in Singapore. Note: Links of useful resources are provided here for your convenience, these documents are published by their respective owner and should be used under their terms and conditions. GDPMDS.COM assumes no liability of using these documents. Global Harmonization Task Force. Global Harmonization Task Force. Medical Device Registration with HSA. GN-12 Guidance on Grouping of Medical Devices for Product Registration. Medical Device Regulatory Timelines.

2

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Good Distribution Practice for Medical Device in Singapore. Medical Device Regulatory Timelines. The Health Products Act 2007 came into operation on 1st Nov 2007. Last day for submitting Class C and Class D Medical Device for inclusion onto H.S.A.’s Transition List. (Note: Submitted dossier will be subjected to screening and evaluation). From 10 August 2010. From 10 August 2010. From 10 August 2010. From 01 January 2012. The above information is subject to change, please check with H.S.A. for...

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Good Distribution Practice for Medical Device in Singapore. How to obtain the GDPMDS Certificate, Importer Licence and Wholesaler Licence. First you need to set up a Quality Management System that comply to the GDPMDS requirements. You can contact one of the professional consulting companies to set one up for you and guide you in the implementation of the quality management system. Procedures and Work Instructions,. Medical Device Regulatory Consultancy. QMS, SOP, WI. AJA REGISTRARS PTE LTD. Companies wi...

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Good Distribution Practice for Medical Device in Singapore. T o find out whether the product you are handling is considered as a medical device, you can test it with the following definition of medical device:. Means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:. A) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:.

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Good Distribution Practice for Medical Device in Singapore. Medical Device Regulatory Timelines. The Health Products Act 2007 came into operation on 1st Nov 2007. Last day for submitting Class C and Class D Medical Device for inclusion onto H.S.A.’s Transition List. (Note: Submitted dossier will be subjected to screening and evaluation). From 10 August 2010. From 10 August 2010. From 10 August 2010. From 01 January 2012. The above information is subject to change, please check with H.S.A. for...Medical D...

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Good Distribution Practice for Medical Device in Singapore. Companies that are involved in wholesaling and/or importing Medical Devices in Singapore are required to pass the GDPMDS certification audit prior to applying for Importer or Wholesaler’s Licence . In order to be certified by the certification bodies, companies are required to have implemented a quality management system that adheres to current good distribution practices. Companies are encourage to get certified early and apply for their licenc...

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