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the 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.
The 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 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.
On 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.
India 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.
Hand sanitizers are not considered medical devices and therefore, do NOT need approval from the Health Sciences Authority (HSA) in Singapore.
On December 31st, 2020, the Ministry of Health (MoH) issued Circular No. 30/2020 providing a list of medical equipment subject to annual safety inspections and technical capability assessments, along with the timelines for implementation.
On December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.
On January 4th, the Philippines FDA released FDA Circular 2021-002. This Circular outlines new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.
FDA’s Circular No. 2020-035 will take into effect immediately, and will pertain to the conduct of licensing inspection for radiation facilities in particular.