Taiwan Food and Drugs Administration (FDA) has published draft guidance covering the regulations related to the special measures to be taken to ensure the safety of medical devices in the context of post-market surveillance. Together with the guidance on adverse event reporting, the document constitutes a part of the Taiwan framework for post-market activities.
A notice published by the Taiwan FDA describes the surveillance measures to be taken by the regulating authorities in order to monitor the safety of medical devices marketed in the country, and also the corresponding obligations of the medical device manufacturers and other parties involved in operations with medical devices.
The document is actually based on current Taiwan regulations on surveillance for medical devices, including the country’s laws and regulations of the Ministry of Healthcare.
According to the general rule, the medical device manufacturer shall ensure the safety of the device in accordance with the announced or approved safety monitoring plan. Healthcare institutions should assist the suppliers by providing the necessary safety-related information. At the same time, medical device suppliers shall prepare the safety reports on a regular basis and provide them with the regulating authority. Current Taiwan regulations on surveillance for medical devices already prescribe the information to be included in those reports, the monitoring period, and the way the initial data should be collected.
In general, the Taiwan FDA guidelines cover the following aspects:
- Legal basis of the surveillance measures,
- Sphere of application of surveillance measures and their actual implementation,
- Regulation on surveillance period,
- Regulations on the surveillance plan development,
- The rules regarding the way the reports should be provided,
- Regulations on the surveillance procedures for medical devices,
- Rules of keeping the surveillance-related documentation,
- Rules for orphaned devices (those for which the manufacturer ceased to exist),
- Regulations to be applied in case of license transmission,
- Surveillance measures based on the regulations on human studies,
- Personal data protection in the context of surveillance for medical devices,
- Additional related matters.
Surveillance Measures for Medical Devices in Detail
According to the document, all surveillance measures for medical devices described therein are compliant with the applicable laws on medical devices. The Taiwan FDA states that in accordance with the applicable regulations in the context of surveillance measures, the regulating authority is entitled to issue special prescriptions mandatory for all industry representatives. In particular, the authority may require to expand to improve surveillance measures carried out by the responsible entity. In some cases, the authority has a right to require to suspend the manufacturing, importation, or distribution of medical devices. If the risks associated with the use of the medical device in question are significant, the authority could also withdraw the license. The regulating authority also determines the content of the report, the terms of its submission, monitoring period, key aspects to be considered, and other related matters.
The document also outlines the sphere of responsibility of the entity holding the appropriate license associated with the medical device and thus responsible for its safety and performance. In particular, the Taiwan surveillance rules for medical devices are based on the following:
- Collection and analysis of the data related to medical devices, including the number of internal and external users, side effects, and all related documentation.
- The obligation of the responsible entity to follow the plan of regular communications with particular users.
According to the general rule, the initial surveillance period constitutes three years from the date of registration or announcement, while the regulating authority is entitled to extend the surveillance period even upon its expiration.
As it was already mentioned before, the entity responsible for the medical device properly placed on the Taiwan market shall develop and follow a post-market surveillance plan. The format and content of such a plan are determined by the regulating authority. The final version of the surveillance plan developed by the responsible entity is also subject to the approval by the regulating authority. The present guidance issued by the Taiwan FDA also contains the list of questions to be covered by the plan.
One of the most important rules in the sphere of surveillance for medical devices relates to the reporting obligations of the responsible entity. According to the applicable regulations, the license holder shall submit reports on safety-related matters on a regular basis. The first regular report should be submitted in 6 months from the initial commencement date. The information should be published within 30 days from the date the reporting obligation becomes due. The regulating authority is also entitled to require the responsible entity to provide additional information or to expand the scope of surveillance. The information collected in the course of post-market surveillance should be stored for 5 years after the expiration of the surveillance period.
Special Surveillance Rules and Provisions
According to the Taiwan regulations on surveillance for medical devices, in case if the license holder intends to cease its business activity, an appropriate notification should be submitted to the regulating authority, and the latter will take the measures necessary to ensure the uninterrupted monitoring.
In case of the license transmission, the initial license holder shall duly transfer all safety-related information to the new responsible entity, providing that the term such information should be kept has not expired. The new responsible entity shall sustain compliance with the applicable surveillance requirements and continue ongoing monitoring of the safety-related aspects.
Special attention should be also paid in case of clinical testing with the involvement of humans. According to the guidance, such testing should be performed in accordance with the applicable laws on clinical trials. Special rules should be also applied in the context of personal data protection. This becomes especially important since the data related to adverse events contains sensitive data of the patients that should be prohibited from unauthorized access or unalloyed disclosure. All aspects related to the operations with personal data should be compliant with the applicable personal data protection regulations.
As was mentioned before, the Taiwan FDA also outlines the key points to be covered by the surveillance plan the license holder shall prepare, approve with the regulating authority and duly fulfill within the whole surveillance period.
According to the document, the surveillance plan shall contain the following elements:
- General information including the project number, the date, and version of the plan, and also the list of previous versions.
- General information about the product including the license number, name of the product in both Chinese and English, model of the product, the name of the manufacturer, the country of origin, the information on the license holder or other responsible entity, and also the readings to be monitored.
- Information about the project, including the grounds for surveillance, key control points, and implementation methods.
- Charts/attachment describing the elements and format of data collection, the format the report should be provided in.
Summarizing the information provided here above, the Taiwan rules on surveillance for medical devices cover the most important aspects related to the continuous monitoring of the safety and correct performance of medical devices properly placed on the market. The rules prescribe the detailed requirements the medical device manufacturers shall follow in the context of safety data collection, analysis, and reporting. The Taiwan FDA also describes special measures to be taken in certain specific situations, such as license transmission or suspension of the business activity by the responsible entity.
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