Importing Medical Devices to Save Lives From COVID-19

Face masks are currently in high demand from all segments of Thai society, particularly medical staff who are at the front line in tackling the COVID-19 pandemic. At the current stage, domestic production is unable to meet demand, and so an increase in imported face masks is one alternative under consideration.

There is some debate as to why certain types of face masks can easily be imported, whereas others are much more difficult to import. Surgical masks are one type of face mask that are part of the debate.

Surgical masks are classified by law as a type of “medical device” based on their purpose of use.  For instance, surgical masks which assist in preventing the spread of disease fall within the definition of a “medical device” under Section 4 of Medical Devices Act. To proceed the import, the Harmonized Commodity Description and Coding System Code (HS Code) can also be referred to in deciding if a face mask is required an import license.  Surgical masks fall under HS Code no. 6307.90.40, the import of which requires an import license from the Thai Food and Drug Administration (FDA). The import license must be obtained prior to customs clearance, and failure to do so will subject any face mask import to liability under the Customs Act. A link to checking the HS Code is as follows:

A surgical mask that is classified as a “medical device” under the Medical Devices Act shall be subject to the provisions of such act, and in order to import such surgical masks the following steps must be taken by the prospective importer.

  1. Under Section 15 of Medical Devices Act, a prospective importer must register with the Medical Device Control Division. If the prospective importer is a juristic entity, then it must have been established under Thai law and located in Thailand in order to register with the Medical Device Control Division.
  2. Furthermore, the prospective importer is required to obtain a license for Imported Licensed Medical Devices. This license is valid for five calendar years.
  3. Once the license for Imported Licensed Medical Devices has been granted, the prospective importer needs to register the medical device that is being imported. Various supporting documentation is required for registration, including a Certificate of Free Sale (CFS), which is issued by the health authority in the country of origin and certified by the Royal Thai Embassy in the country of origin. In case the product is not considered a medical device in the country of origin, a Chamber or an Association can issue the CFS instead of the health authority in the country of origin.

In response to the rapid spread of COVID-19 and the desire to prevent any shortage of medical devices in the country, the Secretary-General to the Food and Drug Administration has issued a Notification streamlining the above process for importing medical devices such as surgical masks.  In particular, certification of the CFS, ISO 13485 certification or a Good Manufacturing Practice (GMP) certificate by a Royal Thai Embassy is temporarily waived.

However, once the country has recovered from the COVID-19 pandemic, the waiver is expected to be lifted.

Please note that surgical masks are now considered controlled goods, and thus prior to their distribution or sale, recent regulations by the Department of Internal Trade need to be followed.