• 2024-09-17 03:17:46

Indonesia's Ministry of Health has issued Regulation No. 3 Year 2024 as a new derivative to the previous halal regulations on medical devices, providing a more specific outline on the mandate for medical device halal certification. This regulation introduces stringent requirements for manufacturing, labeling, and material disclosure.

• 2024-07-30 02:55:19

Thailand's Ministry of Public Health is enforcing stricter rules for dental devices. Specific dental products like implants and orthodontic instruments can only be sold to certified dentists and approved healthcare providers. Distributors must have selling approval certificates for transparent distribution. These changes aim to enhance patient safety and raise dental care standards, requiring quick adaptation from stakeholders.

• 2024-06-20 07:20:10

Considering expanding your medical device business to Brazil or Southeast Asia? Qualtech Consulting Corporation's recent webinar can help! This informative session explored navigating the regulatory landscapes in these rapidly growing markets.

• 2024-06-19 09:02:05

This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.

• 2024-05-02 01:55:12

Join our FREE webinar on ASEAN Regulatory Updates & Brazil's Medical Device Regulations. Learn how to stay compliant and enter the Brazil market! Sign up today!

• 2024-06-27 05:11:25

This article provides a comprehensive guide on TGA sponsors, a critical partner for medical device companies seeking to enter the Australian market. It explains the role of the Therapeutic Goods Administration (TGA) and how a TGA sponsor acts as a liaison, navigating the complex regulatory process to ensure compliance.

• 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

• 2024-01-26 07:08:51

A regulation on the management of emergency use of medical devices (trial) is issued.

• 2023-11-20 02:49:24

A regulation governing the assignment of Unique Device Identifiers (UDI) for contact lenses has been published.

• 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.