The new article provides additional details regarding the timelines for the implementation of a new UDI system.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system to be implemented to improve traceability and overall safety of medical devices allowed for marketing and use. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature and could be subject to changes, should such changes be reasonably necessary to reflect the respective amendments to the underlying legislation.
The document describes in detail the UDI system itself (including all its key elements and components), the process of implementation, the rules to be applied for specific device types, and also the applicable implementation timeline.
UDI Implementation Timeline: Key Points
First of all, the authority mentions that following the applicable regulatory requirements, all class B, C, or D medical devices including in vitro diagnostics (IVDs) are required to be registered with HSA on the SMDR, before their placement on the Singapore market, while class A medical devices are required to be listed on the Class A medical device database.
To ensure that medical device manufacturers and other parties involved in operations with medical devices have enough time to achieve compliance with the new UDI requirements, the latter will be implemented gradually, on a step-by-step basis following the timeline described herein. The authority also mentions that the approach to the implementation timeline is based on the risks associated with the devices in question. Hence, should a medical device be supplied in the country after the compliance date for the category it belongs to, it should comply with the respective regulatory requirements in terms of unique device identification.
According to the flowchart provided in the guidance, the general implementation timeline should be as follows:
- High-risk implantable medical devices (e.g., coronary stents, orthopedic joint replacement implants & intraocular lens) – 2022;
- All other Class D medical devices – 2024;
- All Class C medical devices – 2026;
- All Class B medical devices – 2028.
The authority also mentions that between the first and second stages the experience of first use of the new UDI system will be rigorously assessed to identify the ways to finalize the database and regulatory requirements. It is also stated that for Class A medical devices the UDI requirements would not be mandatory, however, medical device manufacturers or importers would still be able to implement and follow them voluntarily.
To provide additional clarity, the document also specifies the exact compliance date for different types and categories of medical devices. According to the guidance, they should be as follows:
- All Coronary stents, orthopedic joint replacement implants, and intraocular lens – November 1st, 2022;
- All Class D General medical devices and IVDs – November 1st, 2024;
- All Class C General medical devices and IVDs – November 1st, 2026;
- All Class B General medical devices and IVDs – November 1st, 2028.
The authority also mentions that the unique device identifiers would not be required for the products intended to be used exclusively for clinical research, investigational testing, or clinical trial, as well as for custom-made devices. At the same time, the products approved for marketing and use under the Special Access Route pathway should comply with the respective UDI requirements.
The HSA also reserves the right to change the compliance date specified hereinabove depending on the progress of the previous implementation phase. The parties responsible for medical devices should ensure that all UDI-related information is duly provided before the respective compliance date.
According to the guidance, the parties involved in operations with medical devices subject to UDI requirements will be provided with an additional 6 months period (calculated from the compliance date) that they will be able to use to implement new requirements and ensure compliance thereto. The authority additionally emphasizes that the said transitional period applies to medical devices already imported to the country (before the compliance date). The document also provides an example demonstrating the way the approach described herein should be applied in the case of medical devices covered by the scope of the very first phase:
- Under the general rule, for medical devices that belong to phase 1, all medical devices imported into Singapore from the 1st of November 2022 should be UDI compliant;
- Any local stocks of these medical devices that were previously imported before November 1st, 2022; should be supplied before May 1st, 2023;
- From May 1st, 2023, the supply of medical devices that are in phase 1 should be UDI compliant.
In summary, the present HSA guidance describes in detail the applicable implementation timelines for different types of medical devices subject to UDI requirements. According to the guidance, the implementation schedule and respective compliance dates for different types and categories of medical devices depend on their class under the existing risk-based classification. The document also provides additional clarifications regarding the transitional period within which the medical device manufacturers and importers will be able to take necessary measures to ensure compliance with the UDI-related requirements that apply to the devices they are going to place on the country’s market.
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