Since the period of validity for import product licence is four years, the foreign company must re-apply at six months before expiry.

application material
(1). Application form( must by typing).
(2). Certificate of legal producing qualification.
(3). Certificate of applicant's qualification.
a. applicant's business licence/ register certificate which dealing in medical device.
b. applicant's business licence/ register certificate must in period of validity.
(4). The original producing country (or area)'s certificate for permitting the product into their market as medical device.
(5). The product's technical standard.
(6). The test's report.
(7). The clinical research report.
(8). Product explanation.
(9). Some other material making for judgement.
(10). The product quality guarantee offered by producer.
(11). The trust deed, promises and business licence/ register certificate.
(12). The guarantee for application material's truth.