Latest Headlines
Sales Target Spotlight: China’s Boao Hope CityNovember 24, 2020 - 5:20 pm- China Regulatory and Commercial UpdatesNovember 4, 2020 - 6:21 pm
- Indonesia Market Summary and Registered Devices ReviewOctober 23, 2020 - 7:15 pm
- Thai FDA Ramps Up Documentation Requirements for General Medical DevicesOctober 9, 2020 - 4:40 pm
- Update: India To Require Local Certification of All Power CordsSeptember 24, 2020 - 5:21 pm
- South Korea Releases Guidance for Software using Big Data, AI, and Machine LearningSeptember 18, 2020 - 5:40 pm
- India Seeks Input on Medical Device ClassificationSeptember 15, 2020 - 5:21 pm
- India Seeks Input on IVD Equipment ClassificationSeptember 15, 2020 - 3:44 pm
- CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LISTSeptember 1, 2020 - 4:32 pm
- THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKETAugust 17, 2020 - 9:52 pm
U.S. Medical Device Industry – Open for Business
/in Commercial Services, Latest News, 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 News /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 News /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 News, 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 News /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 DEVICES SHIPMENTS DURING THE COVID-19 PANDEMIC
/in China, COVID-19 IMPORTING DEVICE ALERT, Hong Kong, India, Indonesia, Japan, Latest News, 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 News, 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 News /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.