Thailand

The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (TFDA) is the division which regulates and monitors Quality, Efficiency and Safety of medical devices manufactured, imported and sold in Thailand abide by Medical Device Act, B.E. 2531 (2008). Currently, medical devices are classified into three groups: licensed medical devices (class I), notified medical devices (class II) and general medical devices (class III). In reverse of other classification systems, class I devices have the highest risk. At this moment the legislation is still in development and soon there will be a re-classification of medical devices based on the level of associated risk to comply with the Asean Medical Device Directive.  

To get permission to import a medical device in Thailand, the foreign manufacturer must in all cases provide a Free Sales Certificate (FSC) and a Good Manufacturing Practice (GMP) Certificate from the manufacturing country. 

Local license holder 

Companies without an establishment in Thailand are required to appoint a local authorized representative. This product license holder must be the same as the importer and distributor. Qserve offers a construction for independent product license holding. 

Language

The language of the submission files shall be either in the English or Thai language. Labeling should be in Thai unless the device is only used by professionals, in that case English can be sufficient.

Singapore

The Health Sciences Authority (HSA) is the authority responsible for medical device vigilance and quality control. All medical devices are classified based on risk-based classification rules that can be compared with the classification systems of FDA, European Union, MDB, MHLW and TGA. The classification system knows a Class A, B, C and D, where Class A is low risk and D high risk. All devices must be registered with HSA prior to placing them on the Singapore market unless exempted as some of the low risk non-sterile Class A devices. Submission takes place through the Medical Device Information and Communication System (MEDICS) and registrations do not expire but require an annual retention fee. 

All documentation to support the registration of medical devices must be compiled in the ASEAN Common Submission Dossier Template (CSDT) format.There are abridged, expedited and immediate evaluation routes possible.

Local license holder 

Companies without an establishment in Singapore are required to appoint a local authorized representative. Any company importing medical devices into Singapore is required to hold an importer's license. Importers of medical devices of risk categories other than Class A are required to be certified to GDPMDS as a pre-requisite for licence application.

Language

All documents to be submitted in support of product registration must be provided in English and all information on the labels of medical devices supplied in Singapore must be provided in English, though non-English information may be included as long as it is in consistent with the English information.

Malaysia

The Malaysian Medical Device Authority (MDA) is the authority responsible for medical device vigilance and quality control and needs to approve your product before you can sell it in the Malaysian market. Their legislation framework is based on the IMDRF (former GHTF) and the product registration dossier must be prepared in accordance with ASEAN Common Submission Dossier Template (CSDT). The classification system is risk based and consists of four classes whereas class A is low risk, class B is low medium risk, class C is high medium risk and class D is high risk. All classes need to be registered, also the low risk medical devices. All applications must be submitted online via the Medical Device Centralized Online Application System.

In case a medical device has already obtained market clearance in at least one IMDRF member country, a shorter conformity assessment route is possible. The conformity assessment is conducted by Conformity Assessment Body (CAB), a by the MDA accredited third party.

Local license holder 

Companies without an establishment in Malaysia must appoint a local authorized representative. Only companies that hold a valid establishment license and a GDPMD or ISO13485 certification are allowed to act as local representative. Another option is to set up a local company or subsidiary in Malaysia.

Language

The language of the submission files can be in English. Labeling should be in Malaysian for home health devices, in case the device is only used by professionals English can be sufficient.

What can we do for you?

Registration support in Thailand

 

Registration support in Singapore

 

Registration support in Malaysia

 

Local independent license holding Thailand

 

Local independent license holding Malaysia

 

Local independent license holding Singapore

 

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