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INDONESIA: The National Public Procurement Agency Open E-katalog Registration for Domestic and COVID-19 related Medical Devices – Oct, 2020

INDONESIA: The National Public Procurement Agency Open E-katalog Registration for Domestic and COVID-19 related Medical Devices – Oct, 2020

  • 2020-11-26 03:47:29

In 2020, National Public Procurement Agency (in Indonesia known as LKPP) has opened E-katalog registration for domestic medical device products and several medical products for handling Covid-19. Due to the Covid-19 pandemic, there are several stages in the E-katalog registration process which is carried out online, namely verification / clarification process. However, the price negotiation stage is still carried out face to face. There is also a possibility that e-katalog registration for imported medical products will be opened around this year.

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THAILAND: Food and Drug Administration Announcement Regarding Technical Documents Preparation for Inspection Purpose 2020 – November,2020

THAILAND: Food and Drug Administration Announcement Regarding Technical Documents Preparation for Inspection Purpose 2020 – November,2020

  • 2020-11-26 01:31:52

Thailand is currently gearing up a step closer toward the transition of Thailand future regulation from Policy – based Classification to Risk-based Classification as Thailand’s Food and Drug Administration announced that it is mandatory for importer to prepare Technical Documents (CDST Dossier) upon importation by the period as follows : 1) Class 1, 2 and 3: 13 June 2021. 2) Class 4: 11 September 2021. Licensee who fails to comply with ThaiFDA must be sentence to penalty condition is as follows:
1. Licensed and Notified Medical Device: Shall be liable to imprisonment for a term not exceeding 1 year or fine not exceeding 100,000 THB or both.
2. General Medical Device: Shall be liable to imprisonment for a term not exceeding 6 months or fine not exceeding 50,000 THB or both.

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數位牙科植體研習

數位牙科植體研習

  • 2020-10-28 02:13:28

於2020/11/11(三)至2020/11/12 (四) 09:00-17:30 (GMT+8)期間,我們很榮幸邀請到台北醫學大學牙醫學系的張維仁教授為我們分享數位牙科植體的資訊與課程。

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Post-market surveillance Services

Post-market surveillance Services

  • 2020-11-09 10:51:43

Post-market surveillance has become an inexorable trend around the globe.
Therefore, proactively collect and track the following information of your products is essential and crucial.
-Relative post-market incidents reported (e.g. alerts, AEs, recalls)
-Relevant clinical literatures

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