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QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

  • 2021-10-04 05:18:22

On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.

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QT Analysis: 5 Pivotal Regulation Updates for Medical Devices that You Need to Know from PFDA – September 2021

QT Analysis: 5 Pivotal Regulation Updates for Medical Devices that You Need to Know from PFDA – September 2021

  • 2021-09-28 23:56:41

This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.

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SINGAPORE: Updates Introduced to Pre-Market Registration Guidance Documents – September, 2021

SINGAPORE: Updates Introduced to Pre-Market Registration Guidance Documents – September, 2021

  • 2021-09-29 00:33:56

HSA recently issued updates to some pre-market registration-related guidance documents and technical reference documents. Specifically, the GN-15, GN-17, GN-18, TR-01, and TR-02 were updated. The changes mainly deal with the addition of cybersecurity requirements for medical devices. This is a very important update since it is imperative to protect devices that are used in the healthcare industry from hackers and other cyberthreats.

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AUSTRALIA:  Medical Device Patient Information Leaflets and Implant Cards – September 2021

AUSTRALIA: Medical Device Patient Information Leaflets and Implant Cards – September 2021

  • 2021-09-29 00:29:09

The TGA has recently published a guidance document of an overview for patient information materials. The patient information materials consist of patient information leaflets (PIL) and patient implant cards (PIC), for implantable medical devices and active implantable devices. From December 1st, 2021, all implantable or active implantable devices will require patient implant cards and patient information leaflets, unless they are specifically excluded from these requirements.

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