project of guidance of import / re-export requirements
TRANSCRIPT
Page 1 of 13
1
2
3
4
5
6
7
8
9
10
11 12 13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
Draft for comment purposes (Not for implementation)
Project of Guidance of Import / Re-export Requirements
for Medical Imaging Materials
Page 2 of 13
Table of Content 33
Introduction ................................................................................................................................... 3 34
Purpose ........................................................................................................................................ 3 35
Scope……… ............................................................................................................................... 3 36
Background ................................................................................................................................. 3 37
Requirements ................................................................................................................................. 4 38
Required Documents ..................................................................................................................... 6 39
Flowchart ....................................................................................................................................... 8 40
Annexes........................................................................................................................................... 9 41
Annex (1):.................................................................................................................................. 10 42
Application form for permission to import and re-export electronic medical imaging materials 43
in the unified system .................................................................................................................. 10 44
Annex (2):.................................................................................................................................. 11 45
Disclosure Form of Radioactive Materials, Narcotic Substance or Chemicals Subject to Public 46
Security Control ........................................................................................................................ 11 47
Attestation ................................................................................................................................. 12 48
Annex (3): Definitions & Abbreviations ................................................................................... 13 49
50
51
52
Page 3 of 13
Introduction 53
54
Purpose 55
This guidance is intended to clarify SFDA requirements of importation and re-exportation of 56
medical imaging materials. 57
58
Scope……… 59
This guidance applies to: 60
- Imaging materials used in medical applications (diagnostic/therapeutic). 61
- Importers and exporters of these materials and health service providers. 62
63
Background 64
In accordance with “The Law of Saudi Food and Drug Authority” issued by the Royal Decree No. 65
(M/6) dated on 25/1/1428 H, which entrusted the Saudi Food & Drug Authority to regulate and 66
monitor the food, drug and medical devices & supplies. The SFDA/MDS issued this guide to 67
determine its requirements for importing and re-exporting medical imaging materials in order to 68
ensure the safety and protection of patients, end-users and related parties of the potential hazards 69
resulting to the use of these materials. 70
71
72
73
74
Page 4 of 13
Requirements 75
• Obtain permission from the SFDA to import or re-export of
imaging materials used in medical applications.
• SFDA studies the requests and verifies that the applicant fulfills the
requirements.
1 General
Importers and exporters shall create an account in the unified
system of the SFDA "Ghad System".
Facility shall have a medical device establishment license (MDEL)
by the SFDA.
Providing all application documents stated in the required
documents.
2 SFDA
Prerequisite
Applicant shall submit the request of importing or re-exporting of
imaging materials used in medical applications through the
unified system of the SFDA "Ghad System" with the documents
specified in “Required Documents”, in order to take appropriate
decision with regard to agreeing to clear the shipment or not.
3 Submitting to the
request
Submit the manufacturer invoice.
Ensure the correct packaging and appropriate identification card
for each product.
Adherence to marking packages with identification of either the
consignee or the recipient, or both.
Shall follow the guidelines of ports clearance requirement,
Available at:
https://www.sfda.gov.sa/sites/default/files/2020-10/MDS-G21e.pdf
4 Clearance at
ports of entry
Commitment to the guidelines for storage, transportation and
handling of medical devices and products published on the SFDA's
website:
1) https://www.sfda.gov.sa/ar/medicaldevices/regulations/DocLib/(MDS-G17)ar.pdf
Commitment to the guidelines for storage, transportation and
handling of drugs and pharmaceuticals published on the SFDA 's
website:
5 Written
procedures for
transporting
Page 5 of 13
76
77
78
79
80
1) https://sfda.gov.sa/ar/drug/resources/DocLib2/Drug-SupervisionCustomsPorts.pdf
2) https://sfda.gov.sa/ar/drug/resources/DocLib2/Drug-resource-5456.pdf 3) https://sfda.gov.sa/ar/drug/resources/DocLib2/PHWGuidelines1.pdf
Importers and exporters shall comply with the provisions of the
“Application form for Requesting Permission to Import or Export
Imaging Materials Used in Medical Applications” Appendix (1),
6 Responsibility of
importers and
exporters
Page 6 of 13
Required Documents 81
Notes Required Documents
It is required for importers and exporters.
Healthcare providers are excluded.
Copy of the MDEL for importation or distribution activities (issued by SFDA).
1
It is required only if the imaging material classified as a medical device.
Copy of the MDMA for imaging material classified as a medical device (issued by the SFDA).
Or the device registration number if it is registered as a low-risk device.
2
If applicable. Bill of Lading (BoL).
3
It shall include: - Shipment description (item names) - Marketing / Scientific names. - Quantity (total / detailed). - Unit weight of each item and gross.
Weight of each package. - Unit price of each item. - Production and expiration date. - Batch/lot number.
Copy of manufacturer’s invoice or profoma invoice.
4
It must be stamped by the trade reference in the country of origin.
The original certificate of origin. 5
In addition to an endorsement of conformity to comply with the supervision requirements of one of the countries of the Global Harmony Team (Australia, Canada, Japan, the United States of America and European Union countries).
Endorsing that the shipment conforms to the SFDA regulations for controlling medical devices and products in relation to the identification card and the conditions of supply and / or use.
6
Copy of the manufacturer Quality Management System (QMS) certificate in addition to the Good Manufacuerer Practice (GMP) certificate.
7
Purchase order (PO) or award issued by the beneficiary or customer (in case of importing).
8
Page 7 of 13
Official letter or free sell certificate proving that the materials are sold in the country of origin.
9
See Annex (1),
It should be filled out electronically via Ghad system through the following link: https://ghad.sfda.gov.sa/en/
Application form of importation/ re-exportation of medical imaging materials
10
See Annex (2),
Link to guidelines, requirements and fees:
https://www.sfda.gov.sa/ar/medicaldevices/reg
s/Pages/RequirementsAndConditions.aulation
spx
Link to Disclosure Form of Radioactive Materials, Narcotic Substance or Chemicals Subject to Public Security Control:
https://www.sfda.gov.sa/ar/medicaldevices/reg
DisclosureForm.docx-ulations/DocLib/MD
Fill out the disclosure form. Fill out the pledge.
11
Request letter for the export of medical imaging materials.
Attach the import permit previously granted for the material.
Special requirements for re-export 12
82
83
Page 8 of 13
84
Flowchart 85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
Start
Submit the application
electronically
Required
Documents
Incomple
te
Complete
Already
registered as
drug product Yes
No
Make a recommendation after
the technical study of the
request
Decision
Accept / Reject
End
Op
eratio
ns S
ector
Man
agem
ent o
f imp
ort an
d ex
port
perm
issions
Dru
g S
ector
Med
icines Im
port
Dep
artmen
t
Med
ical Dev
ices &
Pro
du
cts Secto
r
Rad
iation
Health
Execu
tive
Man
agem
ent
Page 9 of 13
108
109
110
111
112
113
114
115
116
117
Annexes 118
119
Page 10 of 13
Annex (1): 120
Application form for permission to import and re-export electronic medical 121
imaging materials in the unified system 122
123
All fields must be filled with descriptive and relevant information in the request for 124
permission to import into the unified system (GHAD) through the following link: 125
126
https://ghad.sfda.gov.sa/ar 127
128
129
130
131
132
133
134
135
136
137
138
139
Page 11 of 13
140
141
142
143
144
Annex (2): 145
Disclosure Form of Radioactive Materials, Narcotic Substance or Chemicals 146
Subject to Public Security Control 147
148
149
150
All fields with descriptive and relevant information must be selected and filled out in the 151
disclosure form via the following link: 152
153
154
https://www.sfda.gov.sa/ar/medicaldevices/regulations/DocLib/MD-DisclosureForm.docx 155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
Page 12 of 13
Attestation 173
174
I certify that the information provided in this document are complete, accurate
and correct. I pledge not to import any of the mentioned products to the non-beneficiary
party of the order. I pledge that all items included in the request are in accordance with
international requirements and specifications, as well as the requirements for
the SFDA. I pledge to abide by the guidelines issued by the SFDA related to storage,
transport and handling. I certify that the shipment does not contain: radioactive materials, drugs,
explosives or any other prohibited material in accordance to the regulations of
public security. I hereby declare that the contents of this shipment are fully and accurately
described in the name of the appropriate shipping, classified, packed, labeled
and placed identification card / installed card on the device. Materials in all
respects are in a suitable condition for transporting in accordance with national
and international requirements and government regulations.
175
Are all or one of the products classified as a medical device / product?
No Yes
…………………………………………………………………
……….
If yes, product name:
…………………………………………………
High risk Classification type:
…………………………………………………
Low risk
176
177
178
179 Date Applicant name Applicant Signature
Page 13 of 13
Annex (3): Definitions & Abbreviations 180
181
KSA Kingdom of Saudi Arabia
SFDA Saudi Food and Drug Authority
MDS Medical Devices Sector
MDEL Medical Device Establishment License
MDMA Medical Devices Marketing Authorization
Facility file
number in the
unified system
Number issued by the SFDA to the entity in accordance with
the Medical Devices Interim Regulation.
Medical device
means any instrument, apparatus, implement, machine,
appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article:
A) Intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific
purpose(s) of:
- Diagnosis, prevention, monitoring, treatment or alleviation of
disease,
- Diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap,
- Investigation, replacement, modification, or support of the
anatomy or of a physiological process,
- Supporting or sustaining life,
- Control of conception,
- Disinfection of medical devices,
- Providing information for medical or diagnostic purposes by
means of in vitro examination of specimens derived from the
human body;
and
B) Which does not achieve its primary intended action in or on
the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its intended
function by such means.
Drug product Any product manufactured in a pharmaceutical form that
contains one or more substances which are used, externally or
internally, to treat human or animal diseases or prevent them.
182