• 2023-05-30 02:10:17

1. Qualtech is Part of Your Team

Given the constantly changing medical device regulatory environment, Qualtech is ready to be an essential part of your RA team. That is, we provide you with one-stop services to navigate you through the different global markets and to expedite your regulatory approvals in your target countries.

• 2023-05-24 07:33:47

Qualtech's big topic article for this month's edition represents an overview of the recent and upcoming changes implemented in the ASEAN countries of Southeast Asia. We thereby cover 6 ASEAN countries and review the most critical and noteworthy changes, so that our readers remain up-to-date and can take required actions in a timeline manner.

• 2023-05-24 07:30:46

To mitigate the risk of nanomaterials, the amendment has been made by the Therapeutic Goods Administration (TGA) to the existing Essential Principle 7 to include the additional obligations. The amended Essential Principles checklist can be viewed and downloaded from TGA’s website.

• 2023-05-24 07:26:30

TGA offers an online publication service to provide market notifications to healthcare providers and/or end users as a result of the EU MDR Transition.

If ALL 6 of the eligibility criteria for streamlined market notifications are met, then the Online Notification Form is to be submitted.
For changes that do not meet ALL six criteria, the new recall notification(s) under TGA compliance will need to be followed.

• 2023-05-24 07:24:05

In order to standardize the management of radiofrequency aesthetic devices, the CMDE issued the “Guidance for the Registration and Review of Radiofrequency Aesthetic Devices”.

• 2023-05-24 07:21:35

The Japanese MHLW has issued a complimentary notice to explain further about cybersecurity of the Essential Principles Requirements.

• 2023-05-24 07:15:51

The applicable expedited route from the Thai FDA supplies much-needed clarity for manufacturers, allowing them to better forecast the potential impact on timelines and costs for certain products. The selection of expedited routes allows applicants to comply according to their medical device approval status.

• 2023-03-29 10:01:23

If you would like to know more about these aspects and many more important regulatory information for the ASEAN markets, you may join Qualtech's ASEAN Regulation Update Webinar on 28 April 2023 (Friday) at 16:00 p.m. – 17:30 p.m. (GMT+8).

• 2023-04-25 02:16:08

Asian medical tourism has grown in popularity in recent years. With a global market share of more than 35%, its market size is predicted to rise at a 15% annual rate. The world's population is aging and increasing wealthy at a rate that high-quality healthcare cannot keep up with. Patients are seeking cross-border healthcare for these reasons. Asian healthcare providers offer world-class medical facilities, highly skilled doctors and medical workers, and a wide range of treatments and procedures at affordable prices. In this article, we will therefore look at Asia's medical tourism business and provide a comprehensive guide.

• 2023-04-25 02:06:51

GB 9706.1-2020 <Medical electrical equipment - Part 1: General requirements for basic safety and essential performance > was announced on 9th April 2020 and has been put into effect from 1st May 2023 onwards. The interpretations and relevant information are provided and have been briefly summarized in this article.