• 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 06:31:20

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 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The US FDA issued a draft guidance for medical devices that have relation to Weight Loss.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 07:45:33

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

• 2023-08-23 06:27:14

Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.

• 2023-08-23 06:20:33

The Australian government has extended medical device reform deadlines due to the EU MDR transition, enabling manufacturers to obtain EU MDR certificates and sponsors to engage with the TGA under the new regulations until July 1, 2029. This adjustment aligns with the EU MDR transition's conclusion on December 31, 2028.

• 2023-08-23 06:00:06

The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.

• 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

• 2023-07-21 03:49:06

The Therapeutic Goods Administration (TGA) will no longer accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices after May 26, 2023. Only approved IVD medical devices supported by ISO 13485 certificates will remain valid until the certificate expires.

• 2023-07-21 03:42:44

NMPA issued <The appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Inspection of Quality Management of Enterprises Providing Medical Device Transportation and Storage Service>.