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- Key Takeaways from VietNam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
- Indonesia Invests in Quality Healthcare Access May 22, 2024
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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.
CHINA WARNS MANUFACTURERS ABOUT RISK ASSESSMENT REPORT DEADLINE
/in China, Latest Updates/by Bryan GilburgAsia Actual works with highly experienced professionals in China that can provide you with accurate and timely Risk Assessment reports for your products that will not only satisfy the NMPA’s requirements but could also be used for updating Clinical Evaluation Reports in other markets.