Medical Devices Import Procedure in Pakistan as per Medical Devices Rules 2015

1. Procedure of Medical Devices Import
Must have
Then
Import of medical devices
Valid medical device
establishment license
Medical device
registration
Within fifteen days of establishing the LC or
remittance, intimate, to the MDB in Form-8.
Application for Import permit
Application on Form-9 & Undertaking on
Form-10 along with Fee 5000 to MDB.
Permit issued in Form-12 for three years.
Intimation on Form-14 with
three invoices copies, a copy of
test report and undertaking on
stamp paper by applicant to
collector of Customs
Sampling by Collector of Custom
for report.
Consignment Intimation

2. **
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Detain OR by providing Undertaking
give consignment to the importer
After report he has to return sample within Ten Days.
If contraventions cannot be remediated
Within two months consignment has
to be exported or surrender to MDB
OR Within Fifteen Days provide representation
against report to the Collector of Custom and he
will forward representation and sample to MDB
for Final report.
If contraventions can be remediated
An officer authorized by MDB may order not to
dispose of the MDs for a period not exceeding one
month after it has been released by the Customs.
And it can be extended for period not exceeding
three months after approval from MDB.
By providing undertaking to the
Collector of Customs consignment can
be imported.