Notice on parallel Imports of medical device
(Importation of gray market goods)
If parallel importer exists in Import Recommendation process, the company needs to apply:
(a) Explanation letter on parallel imports from product owner or manufacturer.
(b) The Original Letter of Authorization from product owner or manufacturer.
(c) Commitment in which the importer has to take responsibilities of products” Post Market Activities after IR approval.
(d) For every Lot No. of imported medical device, the company needs additional notification certificate from Department of Food and Drug Administration.