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- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
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Artificial Intelligence (AI) Software Registration in Singapore
/in Latest Updates, Singapore/by Kenna RasiklalIn December 2019, the Health Sciences Authority (HSA) of Singapore’s Ministry of Health released guidelines regarding software registration in Singapore, including a major section dedicated to AI software.
U.S. Medical Device Industry – Open for Business
/in Commercial Services, Latest Updates, United States/by Mark WeisbrodUncertainty. If there is one word that best describes the global outlook during the 2020 pandemic this might be one that everyone can agree on.
Voluntary Medical Device Registration in Hong Kong
/in Commercial Services, Hong Kong, Latest Updates/by Eric LeungMedical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
INDONESIA E-CATALOGUE MEDICAL DEVICE ENROLLMENT 2020
/in Indonesia, Latest Updates/by Ilham HidayattulahMedical device manufacturers are advised to prepare e-Catalogue applications early and be vigilant for the enrollment announcement. Implementing an optimal pricing strategy will be critical to successful public hospital sales. The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is little room for regional dealer margin under the price scheme.
Philippines Releases US$9M To Hospitals For COVID-19 Response
/in Latest Updates, Philippines/by Glend LlantadaThe PCSO is a major source of funding for new hospital construction and medical device and equipment purchases and is often overlooked by outside suppliers. Medical device manufacturers should discuss with their Philippines distributors about what opportunities are available through the PCSO.
HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES
/in Hong Kong, Latest Updates/by Bryan GilburgBy allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.
Medical Device Shipments During the COVID-19 Pandemic
/in China, COVID-19 IMPORTING DEVICE ALERT, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Russia, Singapore, South Korea, Thailand/by Bryan GilburgCOVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
MALAYSIA IMPLEMENTS ADVERSE EVENTS REPORTING REQUIREMENTS FOR MEDICAL DEVICES
/in Latest Updates, Malaysia/by Bryan GilburgOn July 1st, 2020 the Malaysia Medical Device Authority (MDA) will implement the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.