Getting into the Asian healthcare market is a great way to make money but it is not easy to get started. The rules are different in each country so it is hard to know what to do. The ASEAN Medical Device Directive is trying to make things simpler with the Common Submission Dossier Template. Each country still has its own rules and timelines.

If you want to sell devices in Thailand you have to follow the rules for Thailand medical device registration. You can work with a medical device registration consultant in Malaysia to help you get a license.. You need to know what you are doing or it can take a long time and cost a lot of money.

At Morulaa Health Tech we can help you with this. We are like a partner who knows all the rules in the APAC region. Our teams put together all the papers you need and act like your representative in each country. We are. Know what to do especially when it comes to Thailand medical device registration and working as a medical device registration consultant in Malaysia. We take care of everything to make sure your products follow all the rules.

Here is what we do to help you as your medical device registration consultant in Malaysia:

• We compile all the documents for you

• We act as your representative in each country

• We make sure your products meet all the requirements, especially for Thailand medical device registration

• We oversee everything to make sure you are compliant from start to finish as your medical device registration consultant, in Malaysia.
  
  

1. Thailand Medical Device Registration

To find out if you can register a device in Thailand you need to look at things. The Thai Food and Drug Administration requires that you have an importer who has a license and a company that has a certification that's active which is called ISO 13485 certification. The Thai Food and Drug Administration needs these things to be in place. You have to have an importer and a company with an active ISO 13485 certification to register a device in Thailand. We help you with submitting your files and keeping track of your documents through the official Thai FDA website.

• The requirements and timelines for Thai medical device registration are the following: Class I takes 200 days, Class II takes about 250 days, Class III takes about 250 days,Class IV takes about 300 days.

• You also have to pay government fees:The cost of Class I is 3,100 bhat; then Classes II and III cost 31,000 bhat. The cost of Class IV is 51,000 bhat.

• If something bad happens with your Thailand device, you have to report it. If it is a threat to public health or someone dies or gets hurt really badly, you have to report it within 15 days. If it is not that serious, you have to report it within 30 days.
  
  

2. Singapore Medical Device Registration

To register a device in Singapore, you have to go through the Health Sciences Authority. They use the MEDDEV pathway to do this. The Health Sciences Authority has high standards for medical devices, and you need to follow them. We help you get your technical documents ready and find a local company to work with.

• The timelines to register a device with the HSA in Singapore are:

Class A is immediate, Class B takes about 8 months, Class C takes 11 months, and Class D takes about 14 months.

• You also have to pay government fees:

• Class A costs about $15.

• Class B costs $4,240.

• Class C costs $6,580.

• Class D costs $12,330.

• If something bad happens with your Singapore device, you have to report it:

If it is a threat to public health, you have to report it right away. If someone dies or gets hurt badly, you have to report it within 10 days. If it is not that serious, you have to report it within 30 days.

3. Malaysia Medical Device Registration

Securing Malaysia Medical device registration means engaging with mda malaysia and utilizing the MeDC@St platform. Partnering with an expert medical device registration consultant malaysia is critical, especially given the new mandatory import permit requirements enforced in early 2026 and complex home-use e-labelling rules. We provide your required local authorized representative and structure your technical file and Free Sale Certificate (FSC).

Registration Timelines:

Class A: It takes 6 to 8 weeks. Class B and C: D: It takes 3 to 6 months.

The government fees are as follows:

1. Class A government fees cost RM 750

2. Class B government fees cost RM 1,000.

3. The government fees for Class C are RM 2,000.

4. Class D government fees are RM 3,000.

Vigilance timelines are the following:

1. We report serious public health threats within 48 hours.

2. We report deaths or serious injuries within 10 days.

3. We report serious events within 30 days.
   
   

4. Indonesia Medical Device Registration

The execution of Indonesia Medical device registration requires interfacing with BPOM/ Kemenkes and operating their E-Watch digital system. The market strictly mandates a local importer and translated Indonesian documentation.

1. Registration Timelines:

Class A Notification: We usually get notified within one and a half to two months. Class A registration takes around three to four months. For Class B and C it takes four to five months. For Class D it can take anywhere from five to seven months.

2. Government Fees:

   • Government Fees are what we need to talk about.

   • The Government Fees for a Class A thing is IDR 1,500,000.

   • Government Fees for Class B and Class C are IDR 3,000,000.

   • If you want Class D, the Government Fees will be IDR 5,000,000.

3. Vigilance Timelines:

We respond to public health threats within twenty-four hours. If there's a death or serious injury, we respond within forty-eight hours. For serious events we respond within thirty days.

5. Vietnam Medical Device Registration

To register a device in Vietnam, you need to work with the Ministry of Health and DAV. You must have a representative and provide Vietnamese translations of your documents.

The Vietnam medical device registration process takes time.

Class A and B devices are fast-tracked and take around 3 to 5 working days. Class C and D devices take longer, around 9 to 12 months or more, because they need an evaluation.

The government fees vary. Class A devices cost 500,000 VND . Class B devices cost around 1,500,000 VND,Class C and D devices cost around 3,000,000 VND.

You also need to report any issues.

• If there is a public health threat, you must report it within 24 hours.

• If there is a death or serious injury, you must report it within 15 days.

• If the event is not serious, you must report it within 30 days.
  
  

6. Philippines Medical Device Registration

In the Philippines you need to get a Certificate of Product Registration from the FDA to register a medical device. This process is strict. Requires an active ISO 13485 certification, a free sale certificate and a local agent. The Philippines FDA has a system called the Post-Marketing Alert System, which started in March 2026.

• The registration timelines vary.

Class A devices take 4 to 12 weeks. Class B, C and D devices take 6 to 9 months.

• The government fees are as follows:

• The price of Class A devices is 81,000 Php.

• Class B devices are more expensive; they cost 108,000 Php.

• The Class C devices cost a little more, than Class B devices the price is 111,000 Php.

• Class D devices are expensive, the price of Class D devices is 117,000 Php.

• You have to tell us about any problems that happen.

If there are public health threats we need to know about the public health threats. If someone dies or gets badly hurt you must tell us about the death or serious injuries within 15 days. If something bad happens but it is not serious you still have to tell us about the -serious events and you have to do it within 30 days.

7. Philippines Medical Device Registration

For manufacturers expanding slightly beyond ASEAN, we also facilitate Taiwan TFDA registration. This pathway demands a local Taiwan agent, traditional Chinese documentation, and may involve a manufacturing site inspection.

• Registration takes months for each class.

For Class I it takes one to two months. For Class II it takes around ten to twelve months. For Class III it takes around fourteen to eighteen months.

• The government fees are different for each class too.

1. The fee for Class I is NT$15,000.

2. The fee for Class II is a lot more; it is NT$60,000.

3. We also have Class III and the fee for Class III is NT$100,000.

• If there are serious public health threats or death or serious injuries, we have to report them We have to report these things within fifteen days for both Serious Public Health Threats and Death or Serious Injuries.
  
  

Accelerating Your Thailand Medical Device Registration and ASEAN Strategy

At Morulaa Health Tech, we convert disjointed regional requirements into a singular, predictable commercialization pathway across Southeast Asia. By utilizing our CSDT compilation strategies and independent localized entity representations, you maintain full control of your IP while ensuring rapid, compliant market entry.

As a medical device registration consultant in Malaysia, we make it easy to register devices in Malaysia. We also help with Singapore medical device registration. Our team takes care of the requirements for registering medical devices in Indonesia, Vietnam and the Philippines. We ensure your products meet standards in each market. We guide you through Malaysia medical device registration, Singapore medical device registration, Indonesia medical device registration, Vietnam medical device registration and the Philippines medical device registration. Our goal is to help you succeed in every target market.

Frequently Asked Questions  (FAQ)