APPLICATION MATERIALS

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

Application materials
Application form (must by typing).
Certificate of legal producing qualification.
Certificate of applicant's qualification .
Applicant's business licence/register certificate which dealing in medical device.

Applicant's business licence/register certificate must in period of validity.

The original producing country (or area)'s certificate for permitting the product into their market as medical device.
The product's technical standard.
The test's report.
The clinical research report.
Product explanation.
Some other material making for judgement.
The product quality quarantee offered by producer.
The trust deed, promises and business licence/register certificate.
The guarantee for application material's truth.