• 2023-10-20 08:17:06

The European Commission has published a flowchart helping relevant actors to determine the eligibility, conditions, and deadlines for the placing on the market of certain devices referred to in Article 120 MDR as amended by Regulation 2023/607.

• 2023-10-20 07:21:15

In September 2023, a circular letter issued by Indonesia’s Ministry of Health recommended that distributor license owners conduct post-market testing independently on circulated products. Products with submitted independent post-market test results which are within qualifications will receive a priority benefit in the e-Katalog system.

• 2023-10-20 06:59:35

PMDA revised Technical Standards for some of the class III generic devices. The notices were issued on August 31.

• 2023-10-20 06:51:30

The Medical Device Authority (MDA) announced on 19th September that any event involving registered medical devices that occurs outside of the country is not required to be reported to MDA if the incident has been notified to the regulatory agency in the country where the incident happened and corrective action or precautions have been taken by the manufacturer or establishment.

• 2023-10-20 06:31:20

Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.

• 2023-10-20 06:18:18

The previously-announced 3-stage timeframe for UDI system implementation on Class II and Class III medical devices has now taken full effect in Taiwan. Qualtech reminds all partners to take note of the related UDI requirements.

• 2023-10-20 05:56:00

The US FDA issued a draft guidance for medical devices that have relation to Weight Loss. The purpose of this guidance is to provides recommendations for both clinical and non-clinical testing to support premarket submissions.

• 2023-09-27 07:52:28

Qualtech's webinar on medical device registration in Japan highlighted the critical aspect of reliability inspection. Key topics covered include the registration process, PMDA's role, and the requirements of the reliability inspection. The webinar provided valuable insights into this complex process, facilitated by expert speakers from Qualtech.

• 2023-09-28 06:42:53

理工科技誠摯邀請您參加將於2023年10月20日(星期五)舉行的網路研討會。

• 2023-09-27 07:45:33

NMPA revised the Catalog of Medical Devices Exempt from Clinical Evaluation (2021) and published the Catalog of Medical Devices Exempt from Clinical Evaluation (2023).