Home About Qualtech NEWS JAPAN/OMETA SEMINAR: Common Problems and Questions of Manufacturers in the Vietnamese and Thai Market and Qualtech’s Solutions – August 2019
JAPAN/OMETA SEMINAR: Common Problems and Questions of Manufacturers in the Vietnamese and Thai Market and Qualtech’s Solutions – August 2019

August 12, 2019

The OMETA Seminar in Tokyo has just come to an end, having provided its participants with the opportunity to get updated on several interesting regulatory topics. The one-day workshop is annually held and organized by the Overseas Medical Equipment Technical Assistants (OMETA). Qualtech had again been invited by OMETA – a non-profit organization - to share its expertise and knowledge during the seminar. In the light of current developments, Qualtech therefore decided to provide attending medical device manufacturers with a thorough regulatory overview about the Thailand and Vietnamese market. For those who did not attend the session, we would like to share with you the most interesting questions received during the seminar as well as Qualtech’s answers for your reference:

Section A: Questions Regarding the Regulations in Thailand
Question 1:
Are there any extension periods regarding the implementation of the coming new ThaiFDA regulations? Also, are my medical device approvals attained under the old regulations still valid and effective?

Ø QT’s Answer:

Thailand’s FDA has not yet generated any schedule to implement the new regulations following the ASEAN Medical Device Directive (AMDD). The ThaiFDA has, indeed, announced the Medical Device Act 2019. However, the act simply represents a revision of the Medical Device Act 2008, in which some of the previously undefined terms, such as “accessory” and “registrants”, have been improved. Currently, Thailand is therefore still following the old regulations and the distinction into 3 categories:General MD, MD to be notified, MD to be licensed.

• Question 2:

We were asked by our local distributor to even mention spare parts such as screws in our Free Sales Certificate. Is it really necessary to register those spare parts by submitting the FSC, or are there any other ways to legally import them without ThaiFDA’s registration?

Ø QT’s Answer:
According to ThaiFDA’s Medical Act 2019, you may include the accessories in the FSC to apply for one import license, while the spare parts can be included as accessory. However, you nevertheless still need to include all spare parts in the FSC.

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Qualtech representatives as well as other OMETA lecturers join in together for a group photo.

For a detailed account on the Registration in Thailand, please refer to our Thailand market introduction.

Section B: Questions Regarding the Regulations in Vietnam
Question 3:
Please explain under what conditions one is eligible to apply for Article 25’s Method of Registration in No. 169/2018/ND-CP (fast track as of 2019/1/1). Please also explain the advantages of the Fast Track system.
Ø QT’s Answer:
The advantage of the Fast Track is the quick review of the dossier without the strict requirements of the normal application. In that way, one should generally be able to get approval within 1 month. However, given that the MOH is currently slightly overwhelmed with a massive number of applications, it might not be guaranteed that an approval within this short time can be achieved.

Regarding the eligibility for the fast track, products that meet at least one of the following two condition are eligible to be evaluated under the Fast Track system:

- a) The product shall have circulated in at least 2 of the following countries: Japan, Canada, Australia, USA, or the EU member countries.

- b) The product shall have been circulated in Vietnam before December 31, 2018 and shall meet the following conditions:

→Having circulated for at least 3 years within the timeframe of 5 years to the date of filing;

→There is no warning information regarding the quality and safety of the MD.

Question 4:
I would like to know the current general medical device registration situation in Vietnam. Also, will there be delays regarding the implementation of the new decrees?
Ø QT’s Answer:
Decree 169 has; in fact, already been implemented at the end of 2018 and it represents the amendment to the Decree no. 36/2016/nd-cp. You shall refer to these two Decrees together to understand the new regulations, specifically for Class A products. Furthermore, Qualtech confirmed with Director of MOH - DMEC, who ensured that the Decree for Class B, C, and D will be implemented in January, 2020.

If one applies for the import permit under Circular No. 30/2015, then it takes 4-6 months to get an import permit. On the other hand, if one applies for product registration under Decree 36 and Decree 169/2019, Vietnam’s MoH has started reviewing applications, but has not yet issued any certificates according to our understanding. Until now, the MoH has however received a massive amount of more than 9,200 applications.

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Representatives from Qualtech’s various ASEAN Offices also joined the seminar via video conference. 

Question 5:

I have heard that a change application to the device label in Vietnam is quite strict, and that even minor changes require a change application. Is this true? If yes, could you explain the general device label requirements and the procedures for the change applications. 
Ø QT’s Answer:

According to Decree 36 & Decree 169, the change shall generally be notified within 10 days as follows. In detail, during MD circulation, the holder of the Reg. No. shall notifythe authority within 10 working days from the date of the following changes:

a) A change of address of the product owner or holder of Reg. No.;

b) A change of the name of the holder of the Reg. No.;

c) A change in the name and address of the MDmanufacturerer;

d) A change of the packaging specifications for IVD and MD;
e) A change of warranty facility;
f) A change of the label, change of the IFU, but do not change the instructions.

Question 6:

Please tell me about the general procedures for the technical file submission under Vietnam Decree 169. Specifically, who is the signee? Furthermore, is the submission of the full technical documentation necessary or would only a summary documentation be required?
Ø QT’s Answer:
The Authorized Representative shall submit the application online via their company account. Before July 1st, 2020, CSDT is not required. However, starting from July 1st, CSDT shall be used for Class B, C, D. Within CSDT, the pre-clinical test report, stability test, and other test reports shall be attached according to the summary of verification and validation.

For a more detailed account specifically on the Medical Device Registration in Vietnam, please refer to our Vietnam market introduction.

Section C: Questions Pertaining Multiple ASEAN Countries

Question 7:
Is there any official template available to submit to ThaiFDA and Vietnam MoH for medical device registrations?

We have the general idea to take the necessary information/content from our Japanese certification application documents and STED (following a translation). Would this be sufficient?
Ø QT’s Answer:
Yes, ThaiFDA as well as Vietnam MoH have issued a number of templates and application forms. However, unfortunately, these documents are written in the respective local language. You may certainly take necessary information/content from STED for the technical document preparation. But administrative documents, such as the Free Sales Certificate (FSC) or the Letter of Authorization (LoA), shall be prepared separately according to the local requirements.

Question 8:
What kind of documents are required for ASEAN CSDT to apply for ThaiFDA and Vietnam MOH registrations? Also, in case I have CSDT and other application documents in hand for the Singaporean and Malaysian market, can I use most of these documents for my application with ThaiFDA and Vietnam MOH as well?
Ø QT’s Answer:

→ As for the Thai FDA, please note that CSTD is only required for devices to be notified (Class II) or devices to be licensed. You may use the CSDT for Singapore submission for your application with the Thai FDA, but some documents shall be translated into Thai language.

→ For Vietnam’s MoH, currently most of the document submissions to Singapore’s HSA can; in fact, be used for Vietnam submissions as well. Yet, quite similar to the answer above, some documents shall be translated into Vietnamese, in order to be able to fill in the information in the respective application form or data sheet. Then starting from July 1st, 2020, CSDT will be used for the submission regarding Class B, C, D products.

Question 9:
Please explain who can serve as the license holders in each of the ASEAN countries (the manufacturer, importer, or the distributor)?

Ø QT’s Answer:
In Singapore the so-called “registrant” can either be the importer or wholesaler. In Malaysia importers as well as distributors can serve as the authorized representatives, given that they have a Medical Device Authority (MDA) Establishment License. Indonesia requires this role to be occupied by importers with an IPAK (distributor license) issued by the Ministry of Health (MoH). PFDA in the Philippines on the other hand asks importers to have a so-called License to Operate (LTO). Thailand allows importers with an Establishment Importer License issued by the Thai FDA to serve as the license holder. While Vietnam, according to Decree 36 and Decree 169, permits any local company, which can further be different from the importer and distributor, to be the authorized representative.

OMETA: Overseas Medical Technical Assistants


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Home About Qualtech NEWS JAPAN/OMETA SEMINAR: Common Problems and Questions of Manufacturers in the Vietnamese and Thai Market and Qualtech’s Solutions – August 2019