Guideline on Submission of Documentation for Registration of Medical Devices Page
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TABLE OF CONTENT
ABBREVIATIONS
..................................................................................................................................... 2
ACKNOWLEDGEMENTS
........................................................................................................................ 3
FOREWORD
............................................................................................................................................... 4
INTRODUCTION
....................................................................................................................................... 5
DEFINITION OF TERMS
....................................................................................................................... 6
1.
GENERAL REQUIREMENTS
...................................................................................................... 9
1.1
A
PPLICANT
..................................................................................................................................9
1.2
L
OCAL
R
ESPONSIBLE
P
ERSON
..................................................................................................9
1.3
F
IRST TIME APPLICATION
...........................................................................................................9
1.4
D
OCUMENTATION
.....................................................................................................................10
1.4.1 Language
....................................................................................................................... 10
1.4.2
Paper type and binding
............................................................................................. 10
1.5
C
LASSIFICATION OF MEDICAL DEVICES
.................................................................................10
1.6
P
AYMENT OF FEES AND PROCESSING OF APPLICATIONS
......................................................11
1.6.1
Payment of fees
........................................................................................................... 11
1.6.2
Processing of applications
........................................................................................ 12
1.7
R
EGISTRATION OF THE PRODUCT
...........................................................................................12
1.7.1
Validity of registration
.............................................................................................. 12
1.7.2
Termination of registration
....................................................................................... 13
1.7.3
Appeals
.......................................................................................................................... 13
1.8
A
PPLICATION FOR VARIATION OF A REGISTERED DEVICE
.....................................................13
1.9
A
PPLICATIONS FOR RENEWAL OF REGISTRATION
..................................................................14
2.
DEVICE DETAILS
........................................................................................................................ 15
3.
SUMMARY TECHNICAL DOCUMENTATION
.................................................................... 17
4.
LABELLING REQUIREMENTS
................................................................................................. 21
ANNEX I
.................................................................................................................................................... 22
ANNEX II
................................................................................................................................................... 27
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