Taiwan on Registration of Single-Use Medical Devices

Regulatory Background 

The present document describes the measures implemented by the Taiwan FDA in order to ensure the safety, efficacy, and quality of single-use medical devices allowed to be marketed in the country. The approach utilized by the Taiwan FDA is actually based on the best practices developed and adopted in the United States, European Union, and Japan. The guidance is intended to provide medical device manufacturers with additional information to be considered, and also to highlight the most important aspects in the context of single-use medical devices that could be reprocessed. In particular, the authority pays special attention to the assessment of the material the device in question is composed of. The guidance describes the design and process data, and also the safety and performance verification of reprocessing medical devices.

According to the document, the reprocessing of single-use medical devices should be carried out in accordance with the applicable pharmaceutical laws. In order to ensure the safety of medical devices marketed in Taiwan, the regulating authority is entitled to assess the characteristics of the healthcare products, while medical devices manufacturers are obliged to provide all safety and performance-related data outlined in the guidance. 

The document provides the definition of the most important terms related to the sphere of guidance, namely: 

• Single-use medical device, which is the one that could be used only once by a single patient in a single procedure. Under the general rule, a single-use medical device is not intended to be reprocessed, including cleaning or sterilization, to be used for another patent. Such a device should be marked as «not reusable» or «use only once», providing that the appropriate mark should be included in the packaging, labeling, or other materials supplied with the device.
• Reprocessing refers to all procedures related to the processing of medical devices intended to re-use it safely. These procedures could include cleaning, disinfection, and sterilization, as well as new packaging and functional testing to be performed to ensure the safety, performance, and quality of the device.

Scope and Key Points  

The single-use medical device to be reprocessed should be a product that has the appropriate license, and its use after reprocessing is limited only to the internal use by healthcare institutions and reprocessing at internal manufacturing facilities. 

The general approach to the single-use medical device should be based on its intended purpose and use. The particular reprocessing processes to be applied would actually depend on the post-use conditions of the medical device in question and risks associated thereto. For instance, the guidance highlights the following risks:

1. Some substances could remain after use (e.g. infectious substances or body tissues),
2. Specific substances used for reprocessing, such as detergents, disinfectants, etc., could also remain after reprocessing,
3. The physical, chemical, and functional changes of the material the device is composed of could take place after use and/or reprocessing. 

All the points above should be considered by the medical device manufacturers carrying out the reprocessing of single-use medical devices.

The Taiwan FDA guidance also describes the situations in which the reprocessing should not be applied, namely:

1. In the case that potential risks associated with reprocessing outweigh the benefits,
2. The necessity to use invasive treatment or surgical operation to remove the entire medical device or its part (for example, in case of implantable medical devices),
3. For the devices used for intravascular operations or long-term blood contact,
4. The patient previously was diagnosed or clinically reasonably suspected of Creutzfeldt-Jakob disease.

Single-Use Medical Device Reprocessing Management 

According to the guidance, medical device manufacturing carrying out the reprocessing of medical devices should comply with the applicable standards, the Good Manufacturing Practices for Medical Devices, and other related regulations. They should also pass the inspection to be carried out by the regulating authority and obtain a medical device manufacturing license. The Taiwan FDA additionally emphasizes that the reprocessing process is different from the initial manufacturing of medical devices, hence, additional requirements should be applied.

The medical device manufacturer intended to carry out the activity related to the reprocessing of single-use medical devices should inform the regulating authority and then submit the appropriate application for inspection and registration by filling the application form and paying the review fee. The filled application form should be submitted to the authority together with the documents requested for review.

The reprocessed medical device should be assigned with the same class under the risk-based classification as the initial device. The manufacturer should also implement the measures addressing the risk of cross-infection that may occur. 

Labeling of Reprocessed Medical Devices 

The Taiwan FDA guidance on reprocessing of single-use medical devices also provides additional clarifications regarding the requirements for labeling. In general, the principles established by the pharmaceutical laws should be applied. However, in addition to the information required under the general rule, the following information should be included:

1. Chinese and foreign names of the device should be marked with «Reprocessed»,
2. The intended use of the device indicated in Chinese documentation should be the same as in the original one,
3. The Chinese documentation should contain the original license information, including the product name, the name, and address of the manufacturer, 
4. The label of the product should clearly indicate the product is a recycled and reprocessed medical device, 
5. The product should be marked as a single-use device,
6. The number of reprocessing should be indicated, 
7. The name of the name and address of the manufacturer should be also indicated on the label. 

Technical Documents 

The technical data of reprocessing single-use medical device should include:

1. Product description, including the intended use, performance, materials, structure, drawings, specifications, etc.,
2. Original product license information,
3. The method used for reprocessing of medical device, including the recycling plan,
4. Description of the frequency of product recycling and reprocessing, providing that the frequency is consistent with the functions of the device,
5. A complete description of the reprocessing process, including the appropriate parameters, conditions, and acceptable deviations.

Risk analysis and control should take place at all the steps of the reprocessing process and include hazard identification, risk assessment, and risk control measures. Complete risk analysis and control reports should be prepared and kept by the manufacturer, including the evidence sufficient to justify the conclusion, especially in the part of whether the residual risk is acceptable when compared to the benefit. 

Summarizing the information provided herein, the Taiwan FDA guidance on reprocessing of single-use medical devices covers the most important aspects, such as eligibility of single-use medical devices for recycling and reprocessing, the main risks to be considered by the manufacturers, and also the way the manufacturer should apply for the appropriate license required to carry out such an activity. 

How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.

Sources:

https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=26494