• 2025-06-03 07:01:37

On April 24, 2025, Qualtech hosted a webinar focused on navigating the regulatory landscape for medical devices in India. The session was presented by Mr. Anil Chaudhari, Founder and CEO of Operon Strategist, and Ms. Lakshmi Ranjith, Manager of Regulatory Affairs of Operon Strategist. Together, they provided a detailed overview of India’s regulatory system, including the roles of CDSCO and state licensing authorities, the classification of medical devices by risk level, the registration process, and best practices for compliance. The following summary highlights the key insights and essential regulatory requirements, offering valuable guidance for medical device companies seeking to enter or expand in the India market.

• 2025-05-29 10:06:54

On April 28, the National Medical Products Administration (NMPA) issued the Guidelines for Quality Management of Online Sales of Medical Devices, which will come into effect on October 1, 2025.

• 2025-05-29 09:42:50

Malaysia Medical Device Authority (MDA) authority issues the new guidance documents of Importation of Medical Device for Re-export (IRE), MDA/GD/0069 in March 2025. This guidance document outlines the procedure for importing medical devices into Malaysia for re-export purposes. It is particularly beneficial for importers and manufacturers by providing clear regulatory steps, approval requirements, and compliance guidelines to facilitate smooth procedure.

• 2025-05-06 08:38:10

Stay ahead in China's evolving medical device regulations! Join our FREE webinar to master NMPA registration, technical reviews, and post-market compliance. Gain expert strategies to accelerate approvals and avoid risks—whether entering the market or optimizing compliance. Secure your spot now!

• 2025-04-24 09:48:40

On March 26, 2025, Qualtech hosted a regulatory webinar exploring the process of medical device approval in Australia. The session covered essential topics including device classification, conformity assessment options, ARTG registration steps, sponsor and manufacturer obligations, post-market surveillance, and upcoming UDI requirements. Practical tips and FAQs helped attendees better prepare for TGA submissions and long-term compliance in the Australian market.

• 2025-04-24 03:49:40

The Therapeutic Goods Administration (TGA) has introduced updated regulatory requirements, effective from July 1, 2024, for medical devices containing medicinal, microbial, recombinant, or animal-origin substances. These changes aim to streamline classification rules, update labelling requirements, and broaden the recognition of international regulatory approvals, thereby reducing unnecessary regulatory burdens while maintaining safety standards.

• 2025-04-24 06:13:27

Australia’s implementation of the Unique Device Identification (UDI) system marks a major advancement in medical device traceability and regulatory oversight. This article provides medical device manufacturers with essential guidance on the TGA’s UDI requirements, timelines, and compliance obligations from 2025 through 2030. It also outlines key roles, exemptions, and actionable strategies to support successful market access and patient safety.

• 2025-04-24 07:49:13

The National Medical Products Administration has further adjusted and optimized certain provisions of the Announcement on Matters Concerning the Production of Imported Medical Device Products by Domestic Enterprises in China, originally issued in September 2020.

• 2025-04-24 08:15:56

The National Medical Products Administration has organized and revised the Key Points and Determination Principles for the Inspection of Medical Device Clinical Trial Projects, which will come into effect on May 1, 2025.

• 2025-04-24 08:42:19

HSA's Medical Devices Cluster has released a draft on Best Practices Guide for Medical Device Cybersecurity for stakeholder consultation. The document provides recommendations on cybersecurity best practices for medical devices, focusing on both pre-market and post-market stages of the device's Total Product Lifecycle (TPLC).

This document is targeted for Medical Device Manufacturers and Healthcare providers, and currently available as a draft for consultation. Which opens from 10 March 2025 to 12 May 2025. The feedback can be submitted by filling out the provided template and upload to the established link.