Noi Suwannabot, General Manager of AA Thailand

About Noi Suwannabot

Noi is a veteran of the medical device manufacturing sphere, having worked in the business for over 20 years.

She received her Bachelor’s degree in Science, Medical Technology at Mahidol University and Master’s Degree in IT Management at King Mongkut institute of Technology, Ladkrabang and went on to serve as RA/QA Supervisor at Abbott Diagnostics (IVD), Medtronic and RA/QA Manager at Zimmer Biomet and later, Align Technology. For years she has provided leadership to ensure products meet company objectives and can thoughtfully and efficiently navigate the complex regulatory landscape of Thailand.

Entries by Noi Suwannabot

Thailand Adds Qualified Personnel Requirements for Establishment Licensing

August 23, 2024/in Latest Updates, Thailand/by Noi Suwannabot

Thailand’s Ministry of Public Health issued a new notification affecting medical device establishment licensing and controller qualifications

Software as a Medical Device in Thailand

June 17, 2024/in Latest Updates, Thailand/by Noi Suwannabot

On May 9th, 2024, the Thai Food and Drug Administration issued guidance regarding registration of Software as a Medical Device in Thailand.

Thai FDA Regulatory Documentation Exemptions

April 12, 2024/in Latest Updates, Thailand/by Noi Suwannabot

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.

Thai FDA Reduces Application Review Time

March 13, 2024/in Latest Updates, Thailand/by Noi Suwannabot

On February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.

Thai FDA QMS Updates to Affect GDP, GMP, and GCP

February 14, 2024/in Latest Updates, Thailand/by Noi Suwannabot

Last month, the Thai FDA announced new quality systems requirements that apply to the manufacture and distribution of medical devices, and for conducting clinical trials in Thailand.

Thailand FDA to Decrease Registration Application Processing Times

January 25, 2024/in Latest Updates, Thailand/by Noi Suwannabot

The Thai FDA hosted a seminar for public discussion and training of the full CDST application, which was attended by Asia Actual Thailand personnel. At the event, the Thai FDA announced its intention to decrease the application pre-screening time from 30 days to 1 working day.

Thailand FDA to Improve Medical Device Advertising Review Times

January 22, 2024/in Latest Updates, Thailand/by Noi Suwannabot

In a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated their intention to improve the advertising approval process. Per the Deputy Secretary General, they plan to implement new processes meant to help expedite the approvals of advertisement applications.

Thai FDA Drafting New Guidance for SaMD and AI Device Registration

September 18, 2023/in Latest Updates, Thailand/by Noi Suwannabot

Thai FDA is drafting new guidelines for AI Regulation. The novel characteristics of artificial intelligence (AI) software cause issues with the medical device registration process in most countries. The Thai Food and Drug Administration (Thai FDA) is working to address this important issue, most recently by hosting a meeting with interested parties on July, 2023, which Asia Actual Thailand employees were invited to attend.

Thai FDA Improves Medical Device Application Process

June 27, 2023/in Latest Updates, Thailand/by Noi Suwannabot

In a virtual meeting held June 19, 2023, the Thai Food and Drug Administration (TFDA) discussed several measures aimed at enhancing the management of medical device registration applications. Standing out was the new Regulatory Applicant (RA) program which provides expedited reviews to applications submitted by certified RA’s and the possibility of utilizing External Expert Bodies as an additional review resource.

Thai FDA Issues Guidance on Specialist Review Selection Criteria

February 16, 2023/in Latest Updates, Thailand/by Noi Suwannabot

Get the latest insights on the Specialist Review Guidance for medical device registration in Thailand from the Thai FDA. Learn about the criteria that trigger a Specialist Review and how to potentially avoid it.