What Is the "Novo Lane"?

The Novo Lane provides a prioritized pathway for eligible innovative medical devices applying for listing under MDACS. As of 9 July 2026, 100+ innovative medical devices had been listed under MDACS, demonstrating the application of the initiative to innovative technologies seeking market access in Hong Kong. The Novo Lane focuses on medical devices that demonstrate innovation through their technology, intended application, previous regulatory recognition, or intellectual property.

Eligibility Criteria for Novo Lane

An innovative medical device should possess at least one of the following characteristics to be considered for the Novo Lane:

1. First-of-its-kind technology

The device provides a unique function or technology for which there is no equivalent product on the market. This criterion is intended to recognize medical devices introducing a new technology or function that has not previously been available in the market.

2. Innovation approval in a reference jurisdiction

The device has obtained marketing approval through an innovation-related regulatory pathway in a reference jurisdiction within the past five years. This may include approval obtained through an established innovation or novel medical device program recognized by the relevant regulatory authority.

3. Artificial intelligence features

The medical device incorporates artificial intelligence (AI) features and has been approved in a reference jurisdiction within the past five years. This criterion recognizes medical devices incorporating AI as part of their functions or technology.

4. Recently patented core technology

The device incorporates a core technology that was patented within the past five years. Relevant patent documentation may therefore be an important consideration when assessing whether a product meets the Novo Lane innovation criteria.

What Does This Mean for Medical Device Manufacturers?

The introduction of Novo Lane provides manufacturers with an additional consideration when planning their Hong Kong regulatory strategy.

Manufacturers developing innovative medical devices should assess their products against the Novo Lane criteria at an early stage of the Hong Kong registration process. In particular, manufacturers may consider whether their product has:

• A first-of-its-kind function or technology;
• Approval obtained through an innovation pathway in a reference jurisdiction within the past five years;
• AI functionality supported by recent regulatory approval; or
• A core technology covered by a patent granted within the past five years.

Supporting documentation should be prepared to demonstrate the relevant innovation criterion and its relationship to the medical device being submitted.

Novo Lane and the MDACS Listing Process

Notwithstanding its eligibility for the "Novo Lane", the device shall be supported by the MDACS Conformity Assessment Certificate and/or reference marketing approval certificate(s). Novo Lane does not replace the existing MDACS listing requirements. Medical device applicants must continue to comply with the applicable requirements for listing under MDACS.

Apply now!

The introduction of Novo Lane provides an opportunity for manufacturers of innovative medical devices to seek prioritized processing under Hong Kong MDACS framework. Early assessment of Novo Lane eligibility can help manufacturers identify the appropriate regulatory pathway and prepare supporting evidence before submitting their MDACS listing application. Qualtech Consulting Corporation provides comprehensive regulatory support for Hong Kong medical device registration, including Novo Lane eligibility assessments, dossier reviews, and MDACS listing application preparations.

Qualtech has been a trusted partner for medical device manufacturers for 26+ years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.

Contact us today here to unlock your medical device potential.
 

References

1. [GN-02] Guidance Notes for Listing Class II/III/IV Medical Devices
2. [GN-06] Guidance Notes for Listing Class B/C/D In Vitro Diagnostic (IVD) Medical Devices