□ Domestic □ Class 2

□ Imported □ Class 3 □ Is
□ Export-only Application Form for Registration of Medical Devices a new medical device
□ Is not

Date of application: MM/DD/YYYY Application No.

(I) Original Copy
Name of ※ ※

approved

medical Chinese English

device

Intended

name of

medical

device

Applicant Name of Seal

pharmaceutical

company

Address of

pharmaceutical

company

Full name of person in Seal

charge

plant

Registered Name of manufacturer (If committed, please specify)

items Address

Category

(According to the

MOHW’s regulatory

classification)
 Specification

(Model number)

Prescription:

Performance

Notes Devices with the same name (as shown in the original

IFU) yet of different model numbers (model or type)

may be applied for together; the model numbers are

to be provided in the specification column.

If the products is committed, applicable requirements

of the Regulations for Medicament Contract

Manufacture and Analysis shall be fulfilled.

Do not fill in fields marked with ※.

Please type in Chinese or English when completing this form.

1/2 PQT-02-011
※ Examination result

※ Review result

※ Reviewed by ※ Supervised by ※ Approved by

※ Date ※ Certificate No.

issued

MM/DD/YYYY

※ Notes:

2/2 PQT-02-011