In alignment with the guidelines for licensing requests or notifications of medical device details by individuals, entities, or organizations not listed in the FDA system, the FDA issued this announcement to establish a uniform registration process for medical devices in Thailand.
Licensing and Registration of Medical Devices & Notifications of Medical Devices
The Thailand FDA rolls out the additional requirements for licensing or registering medical devices and for notifying medical device details. Key points include:
1. Holder of Licensing or Registration Rights
The original license holders, or the Product Registration Holders (PRH), must submit original documentation and authorization letters for transfer.
2. Evidence of Device Safety and Quality
Include proof of compliance with regulatory standards and product specifications
3. Transfer of Ownership
In cases of transferring registration or licensing rights, both parties must confirm the registration or licensing's active status and submit required details for approval.
4. Compliance Requirements for Notification of Changes
Any modifications to the registered or licensed medical device details must align with current regulatory standards and be submitted to the authority.
5. Action in Case of Discrepancy or Error
The regulatory authority reserves the right to demand corrections for discrepancies, risking rejection for non-compliance.
Notification of Medical Devices
After the notification of product details or licensing under the Medical Devices Act B.E. 2551, certain guidelines and requirements must be followed to ensure compliance, including proper document submission, before the request or notification can proceed. Key requirements are as follows:
1. Submission of Evidence: The manufacturer must present consent letters, safety certifications, and declarations confirming the device aligns with approved specifications.
2. Registration Status: Active and valid licensing or registration is mandatory, with updates on ownership changes reported promptly
3. Change of Ownership: Both parties are required to follow authorized procedures and submit proper documentation.
4. Submission and Review Process: Authorities may request additional documents or corrections. Non-compliance risks registration suspension or revocation
Notification on Importing Medical Devices
The Ministry of Public Health outlines pre-2022 requirements for unregistered reports related to imported medical devices. These include:
Reports on damages or risks necessitating updated safety measure
Complaints about device safety or performance
Declarations confirming identicality to previously licensed devices, barring minor adjustments
Documentation on adverse effects causofed by active devices, device deficiencies, or public health risks
Stakeholders are encouraged to consult the regulatory body for more information on ensuring compliance with the submission process and maintaining active registration.
Source: Thailand FDA
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