Thai Draft Regulation on Quality System: Overview

Table of Contents

Thailand’s regulatory authority in the sphere of healthcare products has published a document dedicated to the quality system to be developed and implemented by medical device manufacturers in order to ensure the proper quality of medical devices placed on the market in the country, as well as their continuous safety and effectiveness. In particular, the document constitutes a draft law addressing the most important aspects related to the quality system and its key components. Once finalized, it will apply to any and all medical devices manufactured or imported to be marketed and used in Thailand. 

The document establishes the good distribution practices to be followed by all the parties involved in the supply of medical devices in the country. 

Terms and Definitions 

First of all, the document provides definitions of the most important terms and concepts used in the context of medical devices including, inter alia, the following ones: 

• Distribution – pre-release, delivery, and post-delivery activities associated with placing medical devices on the market, defined as making devices available for use irrespective of whether they are new or refurbished, except the cases when the device is being used in medical research or evaluation of its performance. 
• An authorized representative stands for a natural person or legal entity empowered by the product owner to be responsible for and to arrange the provision of medical devices for sale. 
• Installation Qualification (IQ) is defined as the presentation of documentation demonstrating that the installation functions testing and other facilities meet the applicable requirements. 
• Adverse effect (AE) to consumers stands for any event arising from the abnormal operation or deterioration in the characteristics or performance of a medical device, or an error from the use which has caused or may have caused or contributed to the injury of a consumer.
• Field Safety Corrective Action (FSCA) is an action required by the product owner to reduce the risk of a serious threat to public health or the consumer’s risk of serious harm from the use of a medical device. 

Record-Keeping Requirements

The regulation further outlines the key points related to the responsibilities of all the parties involved in the supply of medical devices. First of all, it is stated that market participants are obliged to implement and maintain a management system that complies with good import rules and procedures for the sale of medical devices, including the ones related to identifying and correcting deviations. When applying for approval, the applicant has to develop an organizational structure chart, specifying the responsibilities, authority, and relationships between all the elements thereof. The said chart should also indicate the positions of all the key persons responsible for various aspects related to the supply of medical devices and ensure there is an efficient mechanism of external control in place.

In terms of record-keeping requirements, it is stated that the parties involved in operations with medical devices should duly document the relevant processes in accordance with the applicable regulatory requirements. In particular, such documentation should cover, at least, the following details:

1. Brief history, activities, and responsibilities of the organization;
2. Scope of the management system that complies with good criteria and procedures for the import or sale of medical devices, including details and appropriate reasons for waiving non-compliance or not applying;
3. Necessary implementation steps of good criteria and procedures for the implementation;
4. Documents required by the operator to ensure that a plan has been prepared covering the operations and process controls;
5. Necessary records of good rules and procedures for applying; as well as
6. Other documents or information relevant, such as the location of the building where the activity is carried out or the examination and certification of medical devices that meet the requirements.

Under the general rule, any and all documents should be prepared, approved, signed, and dated by the person authorized to conduct such activities. In case of changes to an authorized person, such an assignment should be properly conducted.

The relevant records should be maintained in a way prescribed by the applicable regulations and guidelines in the sphere of the import or sale of medical devices. The party responsible for a medical device should provide these records to the authority upon request.

Documentation related to a medical device should be kept for the period of time specified by the authority, but not less than the intended shelf life of a medical device, or the service life. According to the regulation, it should be not less than 5 years from the date the device was manufactured, and not less than 2 years from the date the device was delivered.

The appropriate records could be stored in electronic form. It is important to mention that the necessary backup measures are to be duly implemented to prevent data loss.

In summary, the new regulation addresses the main points related to the good distribution practice. The new law provides definitions of the most important terms and concepts used, and also describes the approach to be applied in terms of record-keeping to make sure all the necessary details are duly documented and retained.

Sources:

MDCD Thailand:Thai Draft Regulation on Quality System

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