registration

1. Pre-Requirements for Registration
of Medical Device
Done by: Eng. Jaleela Khalfan Al.Julandany

2. Medical Device Definition
Risk Classification
Introduction
Medical Device Classification
01
02
03
Medical Device Categories
04

3. Medical device definition
Instrument
Apparatus
Appliance
Software
Implant
Reagent
Material
Which doesn’t achieve its primary
intended action on the human body by
Pharmacological, Immunological or
Metabolic reaction
Diagnosis
Prevention
Monitoring
Treatment
Alleviation of disease,
Investigation, Replacement or
Modification
Providing data via In Vitro
examination of samples derived
from a human body
Disinfection and Sterilization
of medical devices
Intended to be used for any of the
following medical purposes:

4. Examples of Medical Devices
&Supplies

5. Risk Classification
( It should be according to the
country of origin jurisdiction)

6. Circular number 182/2021
(Risk Classification of
Medical Device )

7. Risk Classification

8. Risk Classification examples

9. 2. Anesthetic and respiratory devices
1. Active implantable medical devices
3. Dental devices
4. Electro mechanical medical devices
5. Hospital hardware
6. In vitro diagnostic devices
7. Non-active implantable devices
8. Ophthalmic and optical devices
9. Reusable devices
Categories of Medical devices:

10. 10. Single-use devices
11. Assistive products for persons with disability
12. Diagnostic and therapeutic radiation devices
13. Complementary therapy devices
14. Biologically derived devices
15. Healthcare facility products and adaptations
16. Laboratory equipment
17. Medical software
18. Procedure packs
19. Other
 Back to the guide for medical device categories:
https://www.moh.gov.om/documents/16539/0/2%2B6+Categories+MD+Guidance.pdf/b87ea973-2eb6-
cf08-c4c9-67ecacf78dfd

11. Medical Device Classification
01
03 02
Medical Device Classification
service is done through the
Online Portal
Guideline available
Classification
Fees
https://www.moh.gov.om/documents/16539/0/new.pdf
/1b539fc8-0893-4750-c21a-fc9b17ad299b
https://www.moh.gov.om/documents/10181/1759244/Pro
duct+Classification+-+Business+User/d885e530-a030-
4078-92bd-92f245a7d5dc

12. Pre-Requirements
Stages
1 2 3
Before Importing
Medical Device &
Supplies
During Supply/
Marketing of the
Medical Device &
Supplies
After
Supplying/Marketing
Medical Device &
Supplies

13. Life cycle of Medical Devices/ IVD Covered by
regulation

14. Before Importing
Medical Device &
Supplies
Stage 1

15. Manufacturer
/Product
Authorized
Representative
Store Licensing
1 2 3 4
Prior to
Import
Competent
Personnel
5

16. 01
02
03
Manufacturer must has:
• QMS system ISO 13485 or,
ISO 9001( for low class MD)
Product must have:
• Product quality certificate .
e.g : (CE certificate)
• Freely sold in GHTF countries
(US, EU, Canada, Japan, AUS)
Product must be registered before the import
,so that it will not be rejected
Manufacturer
/ Product

17. 1
2
To be a local agent / Authorized Representative
of the factory according to ( Chapter Six /
Article 82 ),in order to ensure the following:
1. Direct contact with the factory
2. Ensure the provision of spare parts and
maintenance requirements
3. Report any accidents or Field Safety corrective
actions related to the product.
 In case the applicant is not the local agent or authorized
Importer:
Applicant has to do his obligation through local agents / Authorized
Representative in Oman.
Authorized
Representative

18. Store
 Applicant must abide with the manufacturer
instructions for following of Storage conditions :
 If the label of the medical device/product does
not include instructions or Phrases related to
conditions of storage, transportation and
handling, Communicate with Manufacturer
for these instructions.
a) Temperature.
b) Moisture content.
c) Exposure to light.
d) Correct position of the
package/container.
e) Maximum number of packages
that can be used.
 Storage, Transportation and Handling
of Sterilized Equipment must be in a
manner that ensures their packages are
tightly closed and protected from the
following:
04
01
03
 The importer must comply with the
storage requirements recommended
by the factory (Chapter 6 article 88).
02
- Getting wet
- Direct sunlight
- Damage
- Dirt and unclean environment
This is to ensure that they are still sterile
when received from the customer.

19. The applicant must add medical device
activity to his Commercial Registry (CR)
1
2
Whole sale activity (if the applicant is
purchasing the device directly from the
manufacturer) (
464904
)
Licensing
Retail Sale activity (If the applicant is
purchasing from local agent in Oman(
(477203)
Note : Retail Sale activity cannot apply
for product registration ,only whole sale
who is authorized from manufacturer.
3

20. 01
Add medical device
activity in the
Commercial
Registry (CR) in
Ministry
of Commerce and
Industry
02
Submit a letter for
requesting approval to
activate the status of
medical device activity
To: Medical Device
Control Department in
Ministry of Health
with a copy of the CR.
03
The approval will
be sent via email to
the applicant
04
Submit the approval to
Ministry of Commerce
and Industry to activate
the status of MD
activity
(ACTIVE )
How to add medical device activity?
( NOT ACTIVE )

21. Format of a letter for
requesting the
approval to activate the
status of medical
device activity

22. During Supply/Marketing
of the Medical Device &
Supplies
Stage 2

23. 01 02 03
Medical Device
Clearance
Requirements:
• Attestation
• Invoice
• ISO certificate
• LPO
• Any other required
Permits

24. Start - Ministry of Health - moh.gov.om
https://www.moh.gov.om/documents/16539/0/Guidance+Document
+GD2-+Online+Medical+Devices+Clearance+22-12-
2020.pdf/21a0b636-fe37-c59d-f2c6-273a411eb178
https://www.moh.gov.om/documents/16539/0/HS+code+for+GCC.
pdf/07d7e994-340c-d7d2-be7d-37c26174a751
Medical Device Clearance
HS code list for GCC
Medical Device Clearance Guidance

25. After
Supplying/Marketing
Medical Devices &
Supplies
Stage 3

26. 5. Commitment to providing after –sales services and providing spare parts to the user
2. It is not permissible to modify or change the medical product without obtaining
the prior approval of the Directorate General of Pharmaceutical and Drug Control
3. Maintaining a database including the details of imported medical devices and
establishing a tracking system for them
4. Safe disposal of medical products and devices according to the manufacturer's
instructions (Chapter Six Article 95)
1. Follow up on updates and circulars related to the regulation of the medical devices
sector issued by the Directorate General of Pharmaceutical and Drug Control

27. 7. Notify the Medical Devices and Supplies Control Department in the event of any
safety warning, malfunction, or notification of any medical equipment or supplies, and
commit to taking corrective measures if necessary
6. Qualification of users of the medical device, according to the manufacturer's
instructions
9. The Directorate shall inspect the facility supplying medical devices and supplies
(Chapter Six Article No. 97)
8. The local agent/applicant must deliver the commercial agency certificate within a
period not exceeding 60 days from the issuance of the conditional approval (the local
agent must communicate with the Ministry of Commerce, the Commercial Agencies
Department to do the necessary)

28. Thanks