• 2026-03-04 08:36:52

Join Qualtech's free webinar, "Medical Device Studies in the US: Regulatory Requirements, Study Design, and Best Practices in Subject Management" on March 26, 2026. This complimentary session is designed to provide clear and practical insights into US regulatory expectations, study design considerations, and effective subject management strategies.

Take advantage of this opportunity to strengthen your understanding of US medical device study requirements

• 2025-09-24 08:22:59

The Medica Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme to streamline approvals for Class B–D devices. The main purpose are to fast-track market access, cutting cost, reducing duplication and enhanced patient care.

• 2025-08-25 03:35:27

The Ministry of Health Malaysia (MOH) has announced an international regulatory collaboration with China National Medical Products Administration (NMPA). This collaboration aims for accelerate pre-market approvals, quicker market access, reduced costs and enhanced patient care while strengthens Malaysia's role as regional regulatory hub.

• 2024-12-16 08:47:55

This guidance clarifies the regulatory framework for the use of EtO in sterilizing medical devices and in vitro diagnostic medical devices.

• 2024-10-08 05:56:39

Join Qualtech's Webinar on India's Medical Device Market and Regulations

• 2024-09-17 06:17:58

Australia's TGA has issued new guidelines for exempt medical devices, clarifying that while not requiring ARTG registration, these products still face strict oversight. Manufacturers must adhere to reporting, recall, advertising, and quality standards to ensure patient safety. Non-compliance can result in penalties.

• 2024-01-26 03:40:25

The FDA has issued a draft guidance to clarify how it reviews real-world data, ensuring its quality for generating evidence that can inform regulatory decisions on medical devices.

• 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.

• 2022-09-27 07:17:48

Utilization of Remote Regulatory Assessments (RRA) as a critical examination of an FDA-regulated establishment and/or its records. FDA has published the draft guidance to let more people understand its value and what FDA expectations for RRA are.

• 2022-08-30 03:46:38

HSA Medical Devices Cluster (MDC) shared a draft guideline for the regulation of Laboratory Developed Tests (LDTs). The regulation’s scope includes laboratories that develop In Vitro Diagnostic (IVD) devices. HSA requests stakeholders to provide comments for further discussion.