[ANALYSIS] Preparing A Common Technical Dossier For Active Medical Devices’ Multi-Country Registrat
In last month’s edition of QT Newsletter, we looked into how active medical devices are regulated in Malaysia, Singapore and Philippines. These countries have strict policies in place, in order to ensure the safety and performance of the devices. So, this month, let’s delve deep into the registration requirements of AMDs in three other blooming ASEAN markets, namely Indonesia, Vietnam and Thailand. These two-part series of articles describe common requirements and differences to take note of, that will significantly reduce the time and resources needed to compile applications for registration in multiple countries.
Table 1: Requirements for registering an AMD in Indonesia, Vietnam and Thailand
Ministry of Health, Indonesia considers registration of AMD as a serious business, as well. Strict regulations are imposed, just as in Singapore and Malaysia. All AMDs, including ones incorporating software and standalone software, must submit international harmonious standards complying test reports to validate devices’ safety and performance, just as listed in the table 2 above. One major difference is that it is mandatory for the manufacturer to have applied for and secured a permit from BAPETEN (Nuclear Energy Regulatory Agency) of Indonesia for all irradiating apparatus prior to submitting for registration with the MOH. Furthermore, instruction for use for all medical devices, irrespective of being active or otherwise, must be provided in local Indonesian language.
In Thailand, the Thai Food and Drug Administration (FDA)’s medical device regulations haven’t been through an advanced level yet, like some other ASEAN counterparts. While all medical devices must be registered with the Thai FDA, only twelve[AM1] type of medical devices are required to be submitted with a CSDT, prior to placing in the market. Of these, only the Physical therapy equipment is an AMD, for which an IFU in local language is necessary. Proof of regulatory approval in the country of origin is a firm requirement for medical device registration in Thailand. Certain documents such as the Free Sale Certificate and ISO certificate must also be authenticated by the territorial Thai Consulate.
Just as in Thailand, Vietnam’s Department of Medical Equipment and Health Works (DMEHW), under the Ministry of Health (MOH), doesn’t place emphasis on the technical documentation to be submitted for an AMD’s registration locally. Registration process of an AMD is no different than for a non-AMD in Vietnam. The requirements are similar. Additionally, instructions for use (IFU) must be provided in local Vietnamese language, in addition to any other international language.
Demand for accessible healthcare in ASEAN market is increasing rapidly due to high population growth rates and epidemiological trends, indicating higher prevalence of chronic diseases and cardiovascular diseases. Local production in these countries is limited to consumables and basic medical devices, opening up a huge void to be filled in by foreign medical device manufacturers. Thus, comparing and understanding the regulatory requirements for AMD in these 6 pertinent ASEAN countries would greatly benefit manufacturers who are eyeing to penetrate the up-and-coming ASEAN medical devices market. In the coming editions of QT Newsletter, we shall discover more on the ASEAN medical device market and how foreign manufacturers can use opportunities presented by local government and authorities, so please don’t forget to subscribe to receive updated regulatory news right to your inbox, on time - everytime!
In order to keep up with these progressive regulatory measures, it would be beneficial to consult with a competent regulatory consulting company such as Qualtech, due its vast experience in Asian Medical Device Registration which has already assisted several foreign manufacturers in complying with current national requirements.