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QT ACTIVITY: Post-Brexit medical device regulatory landscape

QT ACTIVITY: Post-Brexit medical device regulatory landscape

  • 2021-06-04 09:34:53

In this webinar, you will learn more about Brexit and how Geopolitics affects medical device regulations. Our expert will introduce you to UKCA. Moreover, Ms. Fatehi will discuss the transitioning out period and will outline how the future for the U.K. market will look like.

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QT ACTIVITY: 2021年新醫療器材管理法實施重點研討會

QT ACTIVITY: 2021年新醫療器材管理法實施重點研討會

  • 2021-04-20 03:15:16

衛生福利部食品藥物管理署公告「醫療器材管理法」於110年5月1日正式實施。因應近期多項新法令之要求,理工科技顧問股份有限公司舉辦「2021年新醫療器材管理法實施重點」,協助廠商了解醫療器材新法令之要求及相關規定,並討論因應措施。報名日期自即日起至5月21日,額滿為止,敬請廠商踴躍報名!

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China: Notice on Registration of Medical Device Technical Dossier–May, 2021

China: Notice on Registration of Medical Device Technical Dossier–May, 2021

  • 2021-05-22 06:49:37

Recently, NMPA issued a Notice on Registration of Medical Device Technical Dossier (No. 36 of 2021), which will facilitate medical device manufacturers to choose raw materials and key components, simplify registration declaration, improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, and encourage innovation.

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INDONESIA: Government Regulation No. 39/2021 regarding Halal Product Implementation is released – May, 2021

INDONESIA: Government Regulation No. 39/2021 regarding Halal Product Implementation is released – May, 2021

  • 2021-05-22 06:38:30

The Indonesian government has issued regulation no. 39/2021 concerning the implementation of the halal product assurance sector. This will make medical devices containing animal derivatives expected to have halal certification with the following timeline: Class A is enforced starting on 17 October 2026, Class B is on 17 October 2029, and Class C is on 17 October 2034. While for Class D the implementation date hasn't been decided yet.

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MALAYSIA: Application for Medical Device Advertisement Approval – Requirements – May, 2021

MALAYSIA: Application for Medical Device Advertisement Approval – Requirements – May, 2021

  • 2021-05-22 05:17:57

In April 2021, Medical Device Authority (MDA) published new guidelines for the implementation of a medical device regulator system which is listed the requirements for application for medical device advertisement approval. The guidelines are to helps the establishment to comply with the regulations Act 737. These guidelines shall be read together with Guidance Documents of Code of Advertisement (COA).

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