In 2014, the Food and Drug Administration ("FDA") issued a regulation saying that any companies that wished to import health products under the FDA controls must obtain a License Per Invoice ("LPI") prior to their arrival. An LPI was a license applied for through the FDA's e-Service for each shipment, to inform the FDA of the import of health products using the invoices. The FDA would issue an LPI as an acknowledgement and electronically forwarded it to the Customs Department as evidence for customs formalities.
However, from 1 September 2016 onwards, the Customs Department, together with the FDA, will use a new procedure called the National Single Window ("NSW") which is a service system for Restricted Goods Permits, hosted by the Customs Department to facilitate trade by linking together the government and business sectors' databases concerning the information on imports, exports and logistics, in an effort to reduce paperwork. All NSW submissions will be done via e-Customs, and the first phase will be only for the import of health products which involve import entries and import tax payments.
A business operator needs to apply for an account to access NSW, to send and receive import information for health products under the FDA controls. There are two ways to access NSW; through the e-Form of the Customs Department, and through software developed by a software house listed by the Import and Export Inspection Bureau of the FDA.
For the transitional period, the Import and Export Inspection Bureau will inform the Customs Department that they will allow the process of LPI to continue manually, to accommodate the business operators who do not yet have NSW properly installed. However, all business operators must use NSW by of 30 September 2016.