Before marketing medical devices in Thailand, they must first be registered online through the Pre-submission and E-submission system the Thai Food and Drug Administration (FDA) which is managed by the Medical Device Control Division (MDCD) with regulations based on Medical Device Act, B.E. 2551 (2008) dan Medical Device Act (Version 2)B.E. 2562 (2019). Definition of medical devices In Thailand, products that make therapeutic, medical or dental claims are considered medical devices, including aesthetics and software as medical devices. Medical devices containing medicinal ingredients can be registered as medicinal products.

Companies that want to register medical devices in Thailand must first have an Establishment License before making, marketing, or importing medical devices. Only persons with genuine Thai nationality can apply for an Establishment License

Medical devices in Thailand have 4 classifications and are categorized into 3 based on risk and guidance in Annex 2 of the ASEAN Medical Device Directive (AMDD) with the addition of special rules from Thailand itself, which outlines the classification criteria for:

• Class 1 Listing Category

• Class 2 and 3 Notification Category

Kelas 4 Licensing Category.[/list]

In February and March 2021, the latest changes to the registration process for medical devices in Thailand will take effect. For the classification of Thai IVD Medical Devices, it follows the regulations of Annex 2 of the ASEAN Medical Device Directive (AMDD) making 4 categories with additional guidelines and regulations specifically for Thailand.

• Class 1 Listing Category

• Class 2 Notification Category

• Class 3 Notification Category

• Class 4 Licensing Category.

To save costs, time and simplify the application process, the Thai FDA has released a new grouping guide for companies to be able to create groupings in registering medical devices by complying with some special rules to be included in the grouping category.

Thailand divides 6 different categories, in the grouping of medical devices:

• Single

• Family

• System

• Set

• IVD Test Kit

• IVD Cluster

General rules in product grouping that apply to each category, Products to be grouped must have one generic ownership name, Only one as the owner of the product and Products to be grouped must have one general purpose intended.

In applying for registration of medical devices, various documentations are needed in the language accepted for delivery in English. Examples of documents that are commonly requested from applicants are device descriptions, pre-clinical studies, product labeling, instructions for use, risk analysis and regulatory approvals. regulatory approvals.

Any wireless medical device that has wireless technology, such as cellular, RFID, WiFi, Bluetoothmust have a certificate which is a certificate from Customs documentation with National Broadcasting and Telecommunications Commission (NBTC) regulatory requirements. To request approval of a wireless medical device requires several documents such as, NBTC Form, ID card and License Holder Registration, Power of Attorney, Technical Specifications and test reports and Equipment photos. Class A and B wireless medical devices will receive an NBTC Registration number during the registration process, to be included in mandatory product labeling.

FDA The Thai FDA, a division of the Ministry of Public Health, requires Manufacturers to address medical concerns, such as devices or Side Effects (often referred to as AEs), and the Field of Safety Corrective Action (FSCA). Manufacturers who make reports can be submitted in hard copy by sending an email or can be done by uploading the report to Medical Device Problem Reporting System. Reporting guidelines and timeframes for reporting follow AMDD Annex 5.

Reporting device defects or AE is an Action required by the Thai FDA on anyone (outside and within Thailand), who is affected by a medical device when the medical device is suspected to cause:

• Serious threats that can endanger public health

• Causing serious injury to users

• Scientific evidence warns that if the inside rots, it can cause serious illness or death for consumers.

Provisions in making a Field Safety Corrective Action (FSCA) report if the Product Owner takes actions such as:

• Product recall

• Product modification

• Product exchange

• Device destruction

• Updates and changes to safety notices.

Minimum requirements for reporting in order for Thai FDA to evaluate the cause of device defects or AEs, and FSCAs:

• Description of device or AE defects, as well as FSCA

• Device or AE fault location

• Those affected by the incident (only for AE)

• Together with the initial report, health hazard evaluation report or other relevant documentation (only for FSCA).

Adverse Events (AEs) reporting has a certain time limit:

• Serious threats to public health must be reported within 48 hours at the latest

• For events that cause death or serious deterioration of health must be reported within 10 days at the latest

• For events that can result in death or serious deterioration of health due to relapse must be reported within 30 days at the latest.