• 2024-11-05 02:46:36

India's MedTech industry is quickly becoming a key player in global healthcare, driven by government initiatives, rising health awareness, and growing medical tourism. The India MedTech 2024 webinar, hosted by Qualtech Consulting, highlighted trends, challenges, and opportunities in the sector, featuring insights from expert Sandeep Shah. While the market, valued at $11-12 billion, still relies heavily on imports, there is a shift toward local manufacturing and innovation in digital health and AI. With growth prospects in domestic production and rural healthcare, the industry is poised to reach $50 billion by 2030.

• 2024-11-05 02:28:52

Japan is grappling with a growing cancer crisis, which has become the leading cause of death and is expected to increase significantly in the coming decades due to an aging population. To address this, Japan has strengthened its healthcare system by designating hundreds of hospitals as cancer care centers. The rising healthcare burden creates opportunities for innovative medical technologies to improve cancer diagnosis and treatment. With a strong focus on technological advancement and openness to foreign innovation, Japan presents a promising market for medical device manufacturers, where expert regulatory guidance is essential for success.

• 2024-11-05 02:13:00

The Therapeutic Goods Administration (TGA) has issued a reminder to manufacturers and marketers to comply with advertising rules for therapeutic goods, particularly on social media, following a rise in non-compliance cases. Key rules include ensuring ads are truthful, promoting only registered goods, adhering to endorsement guidelines, avoiding unapproved uses, clearly presenting risks and health warnings, and ensuring influencer content meets regulatory standards.

• 2024-11-04 10:27:21

Starting from 1 January 2025, Local Responsible Persons must submit Medical Device Listing Renewal Applications between 12 weeks and 1 year before the expiry of their listing approval. Applications that fail to reach MDD before the 12-week mark will not be processed.

• 2024-11-04 08:50:30

Thai FDA introduced new guidelines for handling the registration of medical devices under Notified (Class 2 & 3) and Licensed (Class 4) Medical Device. Thai FDA permitted referencing of previously approved dossiers when applying for brand name changes ("Refer") and for the transfer of medical device licenses between medical device establishment ("Transfer"). This move aimed to streamline the regulatory process, reduce redundant dossier reviews, and simplify licensing in Thailand's medical device sector.

• 2024-11-04 05:15:38

The US FDA has issued draft guidance outlining recommended methods for chemical analysis in the biocompatibility assessment of medical devices. It advises manufacturers to use targeted analytical techniques to identify and quantify chemical constituents, focusing on both device material composition and potential patient exposure.

• 2024-10-08 05:56:39

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

• 2024-10-10 10:03:44

The ASEAN region is rapidly emerging as a vital player in the global healthcare industry, offering immense opportunities for growth and expansion. For medical device companies looking to enter this dynamic market, partnering with Qualtech Consulting Corporation provides the expertise, support, and local knowledge necessary to navigate the complexities of regulatory approval and achieve success. Don't miss the chance to expand your business in one of the world's most exciting healthcare markets—let Qualtech guide you every step of the way.

• 2024-10-10 09:41:55

Indonesia is transforming its healthcare system through three major government projects: SIHREN, SOPHI, and INPULS. These initiatives aim to improve healthcare services, enhance access to specialized care, and strengthen the public laboratory system, addressing major diseases like cancer and heart disease. The projects also present significant opportunities for medical device manufacturers and regulatory consultants to align their offerings with Indonesia’s evolving healthcare needs.

• 2024-10-10 09:23:31

The Medical Device Authority (MDA) announced the outcomes and implementation plan for the MDA-CAB 2023 Workshop held on December 6–7, 2023, as well as the current MDA-CAB 2024 Workshop Series I scheduled for March 1, 2024.