The new article provides an overview of flowcharts describing the change type assessment.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements on change notifications for registered medical devices. The document describes the approach to be applied for changes to medical devices that are already allowed for marketing and used in Singapore. The guidance is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should it be necessary to reflect corresponding changes to the underlying legislation.
To assist medical device manufacturers and other parties involved in interpreting the applicable regulatory requirements for change notifications in general and change type assessment in particular, the guidance provides flow charts illustrating the said approach. The flowcharts outline the main principles to be followed when making such a determination and also highlight the key points to be considered. The flowcharts also contain examples to make them clear and understandable. However, the authority additionally emphasizes that the said examples are not exhaustive and are provided for reference purposes only.
The main flow chart provides a general overview and explains the way the proper flowchart is to be determined. The authority recommends the interested parties check the entire flow to make sure that all the changes are identified and taken into consideration.
The document further provides separate flowcharts describing certain specific changes and outlining the actions to be taken by applicants in each of them.
Changes to Manufacturing Facility or QMS
The first flowchart is dedicated to the changes in the manufacturing facility, the processes it employs, and/or the Quality Management System (QMS) implemented by the manufacturer.
According to the flowchart, at the very first step, the applicant should check whether the changes in question affect only medical substances while leaving the medical device itself intact (in the case of combination products). In this situation, the applicant is encouraged to get in touch with the Medical Devices Branch to get additional clarifications.
As further described in the flowchart, the following principles should be applied:
- Changes to the manufacturing process to Additive Manufacturing or refurbishing a medical device already placed on the market require a Technical procedure for Class C&D products, and a Notification procedure for Class B ones.
- The same approach should be applied in case of a change in the manufacturing process that results in a change in the specifications of a registered medical device.
- In case the manufacturer intends to add a new manufacturing facility or remove an existing one, without making changes to the manufacturing process itself, a Notification procedure should be applied irrespective of the class of a medical device affected.
- The approach described hereinabove should also be applied in case the changes are limited to an update of the QMS validity date.
The second flowchart describes the approach to be applied to changes related to a sterilization facility or respective processes. Under the general rule, changes in sterilization method used by the manufacturer or any processes or procedures associated thereto would require a Technical procedure for Class C&D products, and a Notification procedure for Class B ones. The same approach applies in case of changes to sterile primary packaging. At the same time, the Notification procedure will be sufficient in case of adding a new sterilization facility or removing an existing one.
The third flowchart is dedicated to changes to the design or specification of an in vitro diagnostic (IVD) medical device. In particular, it is stated that a Technical procedure for Class C&D products and a Notification procedure for Class B products would be required in case of changes to the control mechanisms employed, performance characteristics of the product in question, or any changes that require additional preclinical or clinical validation to be conducted.
In the case of general (non-IVD) medical devices, a Technical procedure for Class C&D products, and a Notification procedure for Class B products would be required in case of changes to the control mechanisms/operating principles of the device subject to review, as well as in case of expansion of the approved indications for use, or the changes that require additional preclinical or clinical validation to be conducted to validate compliance with the applicable regulatory requirements in terms of safety and effectiveness.
One of the flowcharts also describes the changes to the software of non-IVD medical devices. The authority additionally clarifies that for guidance, software refers to standalone software and/or software embedded in a medical device system. According to the guidance, a Technical procedure for Class C&D products, and a Notification procedure for Class B products would be required in case of changes:
- Resulting in the modification of an algorithm the software in question employs,
- Related to the addition of new features and/or applications,
- Including the addition or removal of the alarm function,
- That are expected to impact the characteristics of the respective medical device,
- The operating system used,
- That is expected to impact the control of the device.
For all other types of changes, a Notification procedure will be sufficient irrespective of the device class.
In summary, the present guidance provides an overview of the change types and the way they should be determined depending on the nature of such changes and their impact on the safety and effectiveness of the medical device in question. The document contains flow charts illustrating the approach to be applied when making such a determination and also highlights the key points to be considered.
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