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- 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
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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Sales Target Spotlight: Philippines’ St. Luke’s Medical Center
/in Latest Updates, Philippines/by Glend LlantadaSt. Luke’s Medical Center (SLMC) in both Quezon City and Taiguig/Global City are top-tier hospitals with Joint Commission International (JCI) accreditation that operate at the quality of international standards. The use of novel technologies for procedures such as 2D and 3D breast ultrasound, laser dermatology procedures, robotic assisted urological surgeries, etc. make SLMC a great target for innovative medical device manufacturers.
India Temporarily Suspends Customs Duties for Covid-19 Related Medical Devices
/in India, Latest Updates/by Gunjan VermaOn Saturday, the Indian Ministry of Finance released a Notification (No. 28/2021–Customs) exempting the following medical devices from customs duties effective immediately until July 31st. The Notification comes as the Indian government continues to take additional steps to battle the ongoing COVID-19 emergency.
Australia’s TGA Continues Alignment with EU Regulations
/in Australia, Latest Updates/by Bryan Gilburgthe TGA made significant changes concerning software, spinal implants, personalized devices, drug administering products, and companion diagnostics that affect many medical device manufacturers. Additionally, the Active Implantable Devices (AIMD) classification will be absorbed into Class III as of November 25, 2021.
Navigating the New Vietnamese Public Medical Device Pricing Portal
/in Latest Updates, Vietnam/by David VoThe new Medical Device Pricing Portal was opened to the public on November 20th with the goal of setting new international standards for medical device sales transparency. The medical device section is split into 2 sections, the Medical Equipment Price and Pricing Information on Winning Bids. On one side, users can view product listings and on the other, review all final government purchases, including contracted pricing.
China’s Green Pathway Registration for Innovative Medical Devices
/in China, Latest Updates/by Bryan GilburgChina’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.
Thailand Implements New Medical Device Regulations
/in Latest Updates, Thailand/by Bryan GilburgOn February 15th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive.
Invoicing Requirements for Medical Device Software in India
/in India, Latest Updates/by Gunjan VermaIndia is considered a high tax environment with complex requirements, with tax law being in a state of constant change. For those concerned with SaMD invoicing, the process may be complex.
Singapore HSA Regulations on Hand Sanitizers, Masks, Thermometers, and Protective Gear
/in Latest Updates, Singapore/by Kenna RasiklalHand sanitizers are not considered medical devices and therefore, do NOT need approval from the Health Sciences Authority (HSA) in Singapore.