Artificial intelligence (AI) technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. A specific form of AI that is of interest for use in Software as a Medical Device (“SaMD”) applications is the use of algorithm that learns and improves the quality of output it produces, known as a Machine Learning algorithm.

Many ASEAN countries, leading the way as major medical tourism hubs, are receiving more state-of-the-art technologies, including AI Based SaMD. In line with this, local Authorities are also reviewing the necessary regulatory framework for the product lifecycle of these new devices with the twin aims of ensuring the software is safe and effective and allowing for changes to healthcare delivery based on the examination of the mountains of new data that AI and machine learning make possible.

In most ASEAN countries, there are no specific regulations passed yet, to review the safety and performance of AI based SaMD, despite being one of the newest and fastest growing sectors of the healthcare industry. The authorities still employ the same set of requirements based on their registrability and risk classification as other medical devices. However, it must be said that, of late, the emphasis placed on the devices’ risk and cybersecurity management is discernibly higher.

Requirements for Registering AI Based SaMD in Most ASEAN Countries

Being one of the earliest ASEAN countries to be strictly regulating Ai based SaMD, Singapore’s Health Sciences Authority (HSA) has previously released guidelines on registering software in Singapore. The guidelines categorize software into four categories: software embedded in medical devices, standalone software, standalone mobile applications and web-based software. The guidelines are applicable for all kinds of AI employing medical devices, regardless of the level of independence the software has on the hardware.

Essentially, major ASEAN countries including Singapore, Malaysia, Hong Kong, Indonesia, and Vietnam place major emphasis on the Total Product Life Cycle (TPLC) approach of the AI based SaMD. Exceptions at present would be Thailand and Philippines. Thai FDA still classifies AI based SaMD as general medical device. Thus, all that is required to register one in TH would be the Free Sale Certificate, brochure and its UMDNS Code. However, since Thai FDA is looking into implementing risk-based classification and require full CSDT to be ready from June 2021 for Class 1, 2 and 3 and September 2021 for Class 4, more comprehensive documents detailing the AI based SaMD’s safety and performance would be required, just as the above-mentioned ASEAN countries. Philippines FDA, on the other hand, regards any kind of SaMD as a non-registrable medical device, hence bringing it into the Philippines market is relatively easier.  However, this could be different when PFDA starts to implement risk-based classification in 2021 and requirements for registering SaMD would get stricter.                                                                                                                                          

TPLC oversees requirements on management, risk assessment, software verification/validation, change management and traceability through the duration of the software’s life cycle. This is very much similar to the TPLC framework utilized by the US FDA to ensure that the safety and effectiveness of the SaMD is maintained.

Apart from the above-mentioned basic building blocks of a AI based SaMD evaluation, the authorities will also pay special attention to post market surveillance and ongoing model monitoring activities. Manufacturers need to pay special attention to the following requirements while putting together their AI based SaMD’s dossiers.

Description of the machine learning system and algorithm used and the rationale behind choosing these.

Description of processes to ensure data integrity, reliability and validity.

Safety mechanisms meant to detect anomalies and any inconsistencies that would affect the products performance

Software version controls in case roll-backs to a previous version is required

Comparison between the real-world validation data and the training set to ensure that ongoing evaluation is consistent with the original data evaluated.

Validation and verification activities to ensure performance remains within pre-defined boundaries

The level of scrutiny and clinical data required during the application process will be determined by the significance of the information being produced.

  • Requirements for Selling AI Based SaMD in Most ASEAN Countries

All SaMD are still bound by the basic post-registration requirements set on all medical devices in each ASEAN countries, regardless of their physical state. Manufacturers still need to provide the SaMD with regulation-appropriate labels, entailing necessary information, either on the software itself and/or on its physical packaging. The local AR and/or appointed importer or distributors would have to carry out their post market vigilance responsibilities. Each time the AI based SaMD undergoes a software upgrade, manufacturers need to be aware of submitting necessary Change Notification claims with the local Authorities, just as they would with a non-software medical device upgrade/downgrade. Certain software is designed to be downloaded directly from the internet. Manufacturers need to be aware of local tax systems, if their AI based SaMD is such a product and legally adhere to the regulations.


The evolving nature of these technologies has prompted regulatory bodies to create new registration guidelines that apply for the duration of the software’s life cycle. These guidelines will likely adapt as the uses of AI expand in the coming years. Singapore is the first Asian Market to provide guidelines for AI, but other countries are likely to follow suit and release guidance soon, as current regulatory controls are not sufficient for this robust technology.

Qualtech will always keep you in the know with all such latest regulatory updates, just make sure you look out for our monthly Newsletters. We have also assisted several manufacturers to bring in their AI based SaMD to the robust ASEAN market. If you would like to join the bandwagon, feel free to contact us!


  1. 1.  HSA: Regulatory Guidelines for Software Medical Devices
  2. 2.  Medical Software Regulations in Asia 2017