Navigating the New Vietnamese Public Medical Device Pricing Portal

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 Green Pathway Registration for Innovative Medical Devices

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.

Thailand Implements New Medical Device Regulations

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.

CHINA TAKES STEPS TO ENSURE QUALITY OF COVID-19 RELATED EXPORTS

Chinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.

Invoicing Requirements for Medical Device Software in India

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.

Singapore HSA Regulations on Hand Sanitizers, Masks, Thermometers, and Protective Gear

Hand sanitizers are not considered medical devices and therefore, do NOT need approval from the Health Sciences Authority (HSA) in Singapore.

Vietnam to Require Annual Inspection of Certain Medical Equipment

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.

Philippines FDA Announces New Requirement for All Medical Devices

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.

India’s CDSCO Extends List of Notified Devices

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.

Indonesia e-Catalogue to Soon Open for 1,480 Medical Device Categories

The Indonesia Ministry of Health recently announced that they will be opening the e-catalogue enrollment period and will soon begin accepting applications for 1,480 product categories.