Thailand Update – 2021
Welcome to the Arazy Group’s regulatory update. Today’s update is from Thailand.
Today we will cover the regulatory updates that were introduced in December 2019 but were only enforced on February 15, 2021, for Class 2, 3, and 4 and on March 15 for class 1 devices.
New product classification and grouping, New registration fees and timeline, and new registration procedures.
Let's review each update in detail.
Product risk classification. Before December 2019, medical devices and IVD were classified into 3 risk categories: a general medical device for high-risk products, notified medical device for medium-risk products, and a licensed medical device for low-risk products.
Since February 2021, medical devices and IVDs are classified into 4 risk categories; Class one for low-risk products, Class 2 for low to moderate-risk products, class 3 for moderate to high-risk products, and class 4 for high-risk products.
The new product grouping will allow all product classification to be grouped as either a family, a system, a set, an IVD test kit, or an IVD cluster. The devices are grouped based on the following criteria:
they have the same generic proprietary and/or product name, they are sold under a single brand name (meant to be used together as a system), they are intended to be used in combination to achieve a common intended purpose, they are all under the same legal manufacturer, and they are compatible when used together as a system.
If you are looking to register your products in Thailand, consider LICENSALE, our Global MedTech Registration system for fast, and easy market access.
The fees for the registration have increased almost 3 times from previous fees for all product classifications. The review and registration timeline remains the same for classes 2, 3, and 4, and is extended for class 1 devices from a maximum of 60 days to 200 days.
In the old registration procedure, there were 2 registration pathways; For general medical devices, the applicant was only required to conduct CFS verification. While for notified and licensed medical devices, the applicant was required to submit a hard copy of the full dossier manually to the Thai FDA.
In the new registration, there is only 1 registration pathway for all product classification. This new pathway consists of 2 stages, pre-submission, and submission.
All applications are to be made through an online registration system. In the Pre-submission stage, the authority verifies the product risk classification and grouping. In the Submission stage, the authority reviews the technical documents.
Starting Feb 15, 2021, the Thai FDA provided 3 years to implement the new regulatory system. Thai FDA introduced transitional registration schemes: Partial registration and full registration. All existing registered products must be re-registered with the Thai FDA using the Partial Registration Scheme. Under this scheme, some compliance documentation (CSDT) will be waived. However, all new products must undergo full Registration, where complete technical documentation (CSDT) is required.
That’s our update for today. If you have any comments or questions please do not hesitate to email or call us. Check the contact us page on our website for an Arazy Group office near you. Follow Arazy Group on Linkedin to view other countries' regulatory updates, as well as the latest advancements in regulatory affairs technology. Stay safe and keep well.