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 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.
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.
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.
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.
The 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.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
A Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.
On November 18, 2020, the Vietnamese Ministry of Health (MOH) released Decision No. 4353 / QD-BYT officially establishing an Advisory Council to help with the regulatory transition.
The Chinese national government has established a special economic zone on Hainan Island with a focus on medical devices and wellness. Medical device manufacturers seeking sales growth in China should be aware of the Boao Hope City development particularly those with new and innovative devices.