The Health Sciences Authority (HSA) of Singapore has recently unveiled a new initiative aimed at accelerating the registration process for Next Generation Medical Devices (NextGen MD). Effective from 1 July 2024, this groundbreaking move is set to significantly benefit medical device manufacturers by reducing regulatory hurdles in hope to expedited market entry. In this article, we delve into the details of this initiative, its objectives, and how it benefits the industry. 

What is a Next Generation Medical Device? 
Based on HSA explanation during webinar which held on 13 June 2024 a NextGen MD is a term introduced by HSA as a medical device, both general medical device and in-vitro diagnostic, that represents a significant advancement in technology or performance compared to its predecessor. It often incorporates innovative features, improved efficacy, or enhanced safety profiles thus these devices are typically rebranded to distinguish from the former device. To qualify as a NextGen MD, the device must have a previously registered corresponding medical device with the same product owner. 

Eligibility Criteria
Manufacturers seeking to benefit from the NextGen MD Initiative must meet specific criteria. 

1. For the Next Generation Medical Device: 

• Risk Class and Registration Route: 

The NextGen MD must fall within Class B, C, or D (excluding MD-drug combinations) eligible under the FULL route.

• Technical Requirements: 

General Medical Device	In-Vitro Diagnostic Medical Devices
All models in the application must meet ALL of the following criteria when compared with the registered device: Same product type Identical validation for Biocompatibility, Sterilization, AND Shelf-life	All reagents in the application must share ALL of the following criteria when compared with the registered device: Identical formulation AND labelled storage condition Identical intended use and indications for use Identical sample type

Only identical test reports (same report version) previously submitted to HSA can be leveraged

2. For the corresponding Registered Device:
   • Same Product owner and Registrant as the next generation device
   • Registered with HSA via ABRIDGED or FULL Route

• If manufacturer would like to leverage changes made to the registered device, the changes must be registered via a REVIEW or TECHNICAL Change Notification

• Registered as an active listing on SMDR at the point of submission of the next generation device.

The detail information for the requirements could be found in HSA's Webinar Slides.

 

Enrollment and Implementation
To enroll in the initiative, Registrant should submit the necessary documents via MEDICS as outlined in GN-15: Guidance on Medical Device Product Registration along with the NexGen MD Form. An email of the job reference number should be sent to HSA (has_md_info@hsa.gov.sg) upon submission with subject title “NextGen MD Initiative”. 

Participation in the initiative is voluntary; manufacturers can choose whether to opt in. The initiative was effective from 1 July 2024.

 

Key Takeaways from the QnA
The initiatives triggered several questions and curiosities from the industry participants. We compiled several important takeaways from HSA’s answers as below: 

• This initiative is not a new evaluation route, It is meant for new devices that do not qualify for change notification and have to be submitted via full evaluation route therefore the published turn-around-time (TAT) and fees of the FULL evaluation route will apply.
• This initiative is also applicable for priority-review applications. 
• If the NextGen MD has a different risk classification from the registered device, it can still qualify for the initiative provided the eligibility criteria are met. 
• The NextGen MD can leverage more than one registered device data, provided that the eligibility criteria are met. 
• If the submitted application is considered not eligible for the initiative, HSA will proceed per standard FULL evaluation route. 

For more detailed information, refer to the HSA Webinar Slides. 

 

Qualtech Consulting Corporation: Your Partner in NextGen MD Registration

Navigating the complex regulatory landscape of medical device registration can be challenging. Qualtech Consulting Corporation offers expert guidance and support to help manufacturers successfully register their NextGen MDs in Singapore. Our team of experienced professionals can assist with:

• Assessing eligibility for the NextGen MD initiative
• Preparing and submitting required documentation
• Interacting with HSA throughout the registration process

By partnering with Qualtech, you can increase your chances of a smooth and efficient registration process for your NextGen MD.

Contact us today to learn more about how we can help you bring your innovative medical device to market faster.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives. 

 

 

References:
Webinar on NextGen MD Initiative

NextGen MD Initiative Slides (pdf)