Thailand: Overview of regulatory compliance and categorization of medical devices


introduction

In 2015, Thailand, along with other ASEAN members, ratified the ASEAN Medical Device Directive (“AMDD“) in order to align regional regulations governing medical devices. To comply with the terms of the AMDD, Thailand has adopted several amendments, regulations and notifications on the requirements for classification and registration of medical devices. Import and the manufacture of medical devices have recently increased due to the global COVID-19 pandemic. With growing interest in the life sciences and health industry and a global need for medical devices and equipment, an understanding of Thai regulatory regime related to medical devices is important to commercial operators, including importers and manufacturers, in Thailand.

Context – Applicable law

Medical devices in Thailand are generally regulated by the Medical Device Act BE 2551 (2008) (the “Medical Devices ActThe Medical Devices Act includes 3 broad categories of medical devices, as follows:

1. medical devices which require importers and manufacturers to obtain the corresponding licenses from the Food and Drug Administration (“FDA“);

2. medical devices that require importers and manufacturers to register with the FDA; and

3. medical devices requiring notification to the FDA by importers and manufacturers.

The Medical Devices Act, through subordinate regulations and notifications, categorizes and imposes certain registration, notification and / or licensing requirements according to the type of medical device. This briefing will provide an overview of these regulations.

Categories of medical devices

The regulations for the different categories of medical devices are set out in a notification issued by the Ministry of Public Health in 2019 (the “MPH Notice 2019The main factor in determining the category to which a medical device belongs is the associated “risk level”, as determined by the Ministry of Public Health. The corresponding “risk” assessment determines whether an importer or a manufacturer of such a medical device is required to apply for a license, or if that operator must register with the FDA or notify the FDA.

Under the MPH 2019 notification, the risk is based on the potential impact on a person’s body, a person’s health, life, or the public health system. The 2019 MPH notification classified medical devices as 1) In vitro diagnostic medical devices (“IVD medical device“); and 2) Non-in vitro diagnostic medical devices (“Non-IVD medical device“), The risk assessment criteria are as follows:

Detailed categorizations are described in a Notification from the Ministry of Public Health corresponding to each type of medical device. The Secretary General of the FDA has the authority to adjudicate any matter arising from the categorization of medical devices.

Compliance requirements (notification, registration and license)

In December 2020, the Ministry of Public Health issued several ministerial regulations to govern the procedures for applying for the issuance of licenses for the manufacture or import of medical devices. The Ministerial Regulations also covered the registration and issuance of registration certificates for medical devices. These notifications also included procedures for notifying certain medical devices by manufacturers or importers to the Secretary General of the FDA or to the person authorized by the Secretary General of the FDA. In addition, the Ministerial Regulations regulate the procedures for issuing the notification certification of medical devices to manufacturers or importers. (the “MPH 2020 Regulations“). In addition, the Ministry of Public Health has issued several notifications, which entered into force on February 15, 2021, (the”MPH 2020 notifications“) to prescribe the characteristics of each type of medical device and the criteria for the risk assessment of medical devices making it possible to categorize medical devices.

In addition to the above, to manufacture or import medical devices, the manufacturer or importer must register their place of operation with the FDA. Importers and manufacturers must also obtain a license for the manufacture or import of medical devices in accordance with the regulation of the Ministry of Public Health “Re: Application and issuance of a license for the manufacture or import of medical devices” , which came into effect on March 18, 2021. In order to sell certain medical devices (eg, human blood containers, HIV test kits, etc.), sellers must also obtain a license granted by the FDA in accordance with the rules, procedures and conditions set out in the regulations of the Ministry of Public Health. . A seller is prohibited from selling medical devices that are not registered, notified, or authorized by the FDA.

Conclusion

Operators, importers and / or manufacturers engaged in a medical device business should familiarize themselves with the classifications and categorizations of medical devices regulated by the MPH 2020 notifications, including the rules and procedures relating to applications and issuance of licenses, notifications or registration systems. as regulated by MPH 2020 regulations. Based on current FDA interpretation, licenses, registration / notification certificates issued under the Medical Device Act cannot be transferred. Thus, in the event of a change of control of a company or of a merger and acquisition, the licensing, notification / registration procedures may have to be repeated. If you need more information on the issues raised above, please contact the authors in the right column.


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