Regulations
Last Updated: 31 July 2026
The Southeast Asian healthcare market presents with highly attractive growth opportunities. However, the entry into this market is associated with the need to navigate through a complex multi-tier regulatory framework for ASEAN Medical Device Registration. Despite the ASEAN Medical Device Directive (AMDD), which aims to standardize the Common Submission Dossier Template (CSDT), the regional differences still define the particular submission requirements, necessary local presence and time to obtain regulatory approval.
Morulaa Health Tech can help you by ensuring that our technical teams prepare your dossier, act as your local representative and help manage your product through its lifecycle. Below you can find an overview of the specific regulations and market access requirements that need to be navigated through for individual countries.
In Thailand, the main regulatory authority is the Thai Food and Drug Administration (FDA) under the Medical Device Control Division (MDCD). As of 2019, the revised Medical Device Act introduces specific requirements for medical devices in Thailand equivalent to ASEAN Medical Device Directive (AMDD). In Thailand, Thailand Medical Device Registration requires a local importer and ISO 13485 certificate.
We take over the hassle of technical file preparation and document control via the Thai FDA website. By managing all aspects related to regional standards and peculiarities we make the process transparent and predictable. Your entry to the Thai market will be smooth and assured by the competent authority. The table below indicates the timeline and government fees for a Thailand Medical Device Registration.
The Health Sciences Authority (HSA) has a very high standard for Singapore medical device registration. In fact, as of 2026, the HSA achieved the WHO’s highest maturity level classification – level 4, which means their MEDDEV standards are among the most stringent in the world. Of course, this implies that a first-time application must be nothing short of perfect. On the other hand, getting the HSA approval serves as a sort of a “Gold Standard”, greatly facilitating further ASEAN Medical Device Registration in other countries. So, we can help you navigate the process and prepare a winning application that will set you up for success in the other markets.
Our team will analyze your current international certifications and advise you on the best regulatory pathway. We will help you identify and utilize the most appropriate out of the four main registration routes:
Immediate registration is the quickest "Zero wait" option for medical devices featuring multiple international approvals with an excellent three-year safety record;
Expedited registration is an alternative for your medical device with approvals from two or more competent international organizations;
Abridged registration is an option for you if your medical device was already approved by any one of the international reference centers; and
Full registration is a standard and most comprehensive type of registration for medical devices with no previous approvals.
Below table represents the timeline and government cost for Singapore medical device registration.
Malaysia’s regulatory environment is closely related to the ASEAN Medical Device Directive, which requires proper preparation of technical documentation. In order to obtain Malaysia Medical Device Registration, it is necessary to actively manage your own submissions to the government through the MeDC@St portal. This process is made significantly more difficult by the import permit requirements introduced at the beginning of 2026, as well as more stringent e-labelling regulations for home use devices.
That is why our company offers the services of a Malaysia Medical Device Registration consultant, who will take over responsibility for actively managing and accelerating your own submissions. We can save you time and effort in preparing all the necessary documents while also providing you with a mandatory local authorised representative, who can manage your application on the MeDC@St portal. To help you develop a timeline for your own launch, we have prepared a table below, which shows the approximate time periods required for the registration process in Malaysia, as well as the corresponding government fees.
The Indonesia Medical Device Registration procedures are surprisingly straightforward for a market of this size, and Kemenkes, the Indonesian Ministry of Health, has a set of regulatory requirements that largely follow the ASEAN Medical Device Directive. This means that you can utilize the CSDT formatted technical files that you prepare for other markets to help expedite the process. Overall, it's an easy market to get into, if the particular local nuances are taken care of at the beginning of the procedure.
Since local regulations require that you submit documentation through a website known as "e Watch," we can help you avoid the delays and complications associated with this requirement in order to get your devices through the evaluation process as quickly as possible. The fees from the government for Indonesia Medical Device Registration can be found below, along with approximate registration time frames.
Entering the Vietnamese regulatory environment involves a proactive approach, particularly with the renaming of the Infrastructure and Medical Device Administration (IMDA) from DMEC in the first quarter of 2025. Although the government is actively harmonizing the national regulations according to the ASEAN Medical Device Directive, this process is not an easy one. Given that Decree 98/2021 is already active, and licenses of Class C and D have been extended up until the end of 2025 and 2026, it is becoming increasingly difficult to navigate the MA bottleneck.
Our company deals with all the tough work for you, from building a dossier that complies with the CSDT criteria to be submitted to MOH. As our specialists interface with the IMDA on a regular basis and keep track of decree updates, we transform the turbulent period into a clear regulatory path for your product. It is important to note that because of the changing regulatory landscape, completing a Vietnam Medical Device Registration from outside the country proves to be quite challenging. Below is the timeline of the process and the government registration costs for Vietnam Medical Device Registration.
Dealing with the Food and Drug Administration (FDA) in the Philippines for Philippines Medical Device Registration requires you to know the ropes of the CDRRHR – the local regulatory authority. Since the Philippines began to align its risk categorization with the ASEAN medical device directive, the requirements have become even more stringent. For example, the local FDA has established a new mandatory Post Marketing Alert System starting March 2026. To obtain the CPR – Certificate of Product Registration under the new rules, your basic documents need to be in order. This implies that you need to secure a current ISO 13485 certificate and Free Sale Certificate at least, among other things.
Our experts will handle all the local FDA filings on your behalf to assist with your Philippines Medical Device Registration and prepare your technical files accordingly. We take care of your post-market surveillance so that you can concentrate on other aspects of your commercialization. You can use this table as a reference for the current timelines and state fees below
At Morulaa Health Tech we make the fragmented and varying regional requirements predictable in an integrated pathway to the market. By aligning your portfolio with the ASEAN Medical Device Directive you can expect to achieve compliance in any of the regional markets without incurring high delays. Our team of experts can assist you through the complex creation of technical documentation and the establishment of a required local representation to legally place your medical devices on the market. CSDT compilation strategies and independent localized representation to keep you in the driver’s seat.
FAQS
Do I need a representative for medical device registration in Southeast Asia?
Yes. In every Southeast Asian country, foreign manufacturers are obliged to appoint an authorised representative (AR).
Will having a CE Mark or US FDA clearance speed up my registration?
Both CE and FDA approvals do present some advantages. Even though they cannot replace a local registration, they do allow us to use some documents for the registration process in most of the Southeast Asian countries, which will significantly shorten the review time by the local authorities. This, in turn, will shorten the approval process by several months and reduce the overall administrative burden.
How long does the Thailand FDA process actually take?
The process duration varies depending on the classification of your device. As a general guide, you can consider spending 30 days for a simple Class I listing and up to 200 days for a Class I sterile listing. Moderate and high-risk devices (Classes II-IV) generally take between 250 and 300 + days for a technical review.
Is ASEAN Medical Device Registration valid forever in ASEAN Countries?
It is not necessarily so. Although the ASEAN Medical Device Directive unites regional approaches to the regulation of the medical device industry, the requirements in the individual countries may differ. For example, in Singapore your registration is valid forever except for additional annual fees to renew the certificate. In Malaysia, for example, the validity period of the certificate is only 5 years. With Morulaa Health Tech you will always know all the details regarding your registration validity period as we will manage your certificates and registrations.