Digital health is an emerging field that is revolutionizing the way healthcare is delivered. It combines technology, data, and analytics to improve diagnoses, treatment, and patient outcomes. Software-as-a-Medical-Device (SaMD), as a subsector of digital health solutions, is experiencing fast growth in both industry scale and innovations.
With more and more SaMD being rolled out, regulations in this field have become increasingly complex, with more regulatory requirements and greater variations across different countries. Launching a new SaMD product can be a daunting task. The key to business success is regulatory compliance. However, with the right regulatory strategy in place, companies can align their business strategy and regulatory activities to achieve product compliance and go-to-market success.
Therefore, it’s critically important for SaMD manufacturers to understand how software is regulated as a medical device in order to develop a strong and efficient regulatory strategy.
Leveraging our strong domain expertise and over 20 years of consulting experience, RegASK has a proven track record of assisting SaMD manufacturers with their regulatory pathways and commercial success.
From product classification and registration to commercialization, read the case study to know how RegASK helped a digital health company build an optimal regulatory strategy in Asia.
A leading global digital mental healthcare provider has developed an app that delivers Cognitive Behavioural Therapy (CBT) to patients with a range of disorders. The client would like to launch the app in a few Asian countries including Hong Kong, Malaysia and Thailand.
The client wanted to know whether they can commercialize their app and if there is any restriction associated with it in the target markets. To achieve their objective, the client engaged RegASK for its regulatory affairs consulting service.
- Identified the applicable regulatory framework of SaMD in Hong Kong, Malaysia and Thailand;
- Defined which countries require registration of the client’s product and the registration process;
- Analyzed whether the product should be classified as a medical device under existing regulations;
- Assessed the possibilities of launching the client’s software in target markets and commercializing it under the client’s preferred model.
With RegASK’s expertise, the client received critical information to determine the most appropriate regulatory pathway for launching their SaMD product in the target markets.
The regulatory overview and assessment conducted by RegASK helped the client save hundreds of hours searching for regulations and design an optimal regulatory strategy to maximize their chance of success.Read more case studies on medical device
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