Philippines FDA Alters Requirements for Radiation Licensing During COVID-19
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.
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NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
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.
New Advertising Exemption in Thailand
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.
Sales Target Spotlight: China’s Boao Hope City
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.
Vietnamese MOH Establishes New Medical Device Advisory Council
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.
China Regulatory and Commercial Updates
The NMPA has continued to stay busy this year, releasing numerous guidance documents and updates to their regulatory requirements. Here are some of the most important updates from the last few months.
Indonesia Market Summary and Registered Devices Review
In recent years, the government has made healthcare a priority for the 261 million Indonesians, providing a lot of potential for medical device manufacturers of all technology levels. The government has also taken numerous steps to curb corruption through their online e-catalogue and other methods which has helped bring in more foreign companies and investment.
Thai FDA Ramps Up Documentation Requirements for General Medical Devices
With the announcement of The Regulations and Conditions Of Maintaining Technical Documents For Safety And Effectiveness Of The Medical Device, the Thai FDA has begun requiring the local medical device License Holder to provide upon request technical documents for any registered device. As the registration process for most General Medical Devices (all but 10 device types fit into this category) does not involve technical documents, this new requirement will impact most medical devices.
Vietnam Launches Medical Device Pricing Portal
On September 9th, the Vietnamese Ministry of Health (MoH) officially opened the Information Portal of Medical Equipment Pricing. Under the new system, the list price of medical equipment will be published (by configuration) on this Ministry of Health hosted website.