تواصل مع الأقسام
تعطيل التحميل المسبق

اسئلة شائعة

  1. موارد مفيدة
  2. اسئلة شائعة
OFOQ FAQ:


FAQ
Answer
What is ofoq?

 

It is a web-based software developed by Customs Affairs allowing al the governmental 

sector to grant pre-approvals of shipments requests submitted by importers.

What is HS Code?

  The Harmonized Commodity Description and Coding System, or HS Code, was
developed by the World Customs Organization (WCO) which defines it as a
“multipurpose international product nomenclature”.

How can I know if the HS Code require NHRA approval or not?

 

If the HS code mentioned in the invoice is listed on NHRA website then NHRA pre-approval

is required.

How can I get a username and password on ofoq?  

Please visit http://www.ofoq.gov.bh  and send the form available on website to customs 

through this email customs.licensing@customs.gov.bh.

What is the ministry code for medical devices importation?   2251
How can I apply on ofoq?   Please refer to Medical Devices Importation Approval Ofoq Guideline on NHRA website.

How long does it take to get the approval on ofoq?   It takes around 24 Hours - 3 weeks starting from the date of submission.
If my request is rejected, how can I know the reasons of rejection?   Please check ofoq system, the reasons will be mentioned in the “comment box”.

Is there any importation fees?   Importation Fees 
What are the required documents to be submitted on ofoq?   Please refer to ofoq documents requested checklist.
Who can import medical devices?   Bahrain is an open market, if you have a valid CR with an activity allow you to import
medical devices then you can import as per NHRA rules and regulations.

When do NHRA need samples?   In case of importing surgical instruments, contact lenses Or selectly samples sealed from
customs should be provided to NHRA with medical devices samples validation form
and required documents mentioned in the form.
If I want to import a medical device for personnel use (home use), what are the required documents?   Healthcare professional prescription, Invoice, QAC and product catalogue.  

Please refer to Personnel Importation Guideline  

http://www.nhra.bh/Departments/MDR/

 
Is it allowed to import used/refurbished medical device as long as it is in a good condition and function well?   No, it is not allowed to import used/refurbished medical device.
 What are the requirements to import class l, Non Sterile medical devices?    A Declaration of conformity document from the manufacturer should be submitted with the request and can be replaced for QAC & QMC. 

QAC FAQ:
FAQ
Answer
What is Quality Assurance Certificate?   It is a certificate issued be a recognized certifying body ensuring that the medical device is manufactured as per international standards.
Examples of Quality Assurance Certificates.  

FDA, CE Mark, ISO 13485.

When the QAC is rejected?  

The QAC is rejected due to many reasons:

· Not verified.

· Not valid (expired or canceled).

· The scope of certificate not matching with the item.

· Certificate is issued for another manufacture than the one in the invoice

             . Certificate is not issued from a recognized certifying body.

How can I verify the Quality Assurance Certificates?   Visit the website of the certifying body, enter the certificate number and capture (screen shot) the validity OR contact the certifying body by sending an email with a copy of the certificate to be verified and put medical_devices@nhra.bh for more infotmation 
How can I know if the certifying body is recognized or not?  

For CE mark, please visit “European Commission”                          

http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.main

 

For ISO 13485, please visit IAF website:

https://www.iaf.nu//articles/IAF_MEMBERS_SIGNATORIES/4


Medical Devices Classification FAQ:
FAQ
Answer
What is a combined medical device?   It is a Medical devices with Pharma HS code that requires manual approval. Most of these device are mixed with pharmaceutical or chemical materials and does not achieve their action by pharmacological, immunological or metabolic means, used for prevention of illness. It also covers IVD with pharmaceutical or biological materials.
What is a free sale certificate?

 

It is a document issued from the health regulatory authority in country of origin stating that the product can be sold in Europe and the product is classified as a medical device according to the directive 93/42/EEC.

What are the reference countries?  

Reference countries are:please vist the lest of the ref conters under classfation tab. 

Is it enough to have a declaration of conformity from manufacturer stating that the product is a medical device?   No, the product should be classified as a medical device by the Competent Authority in country of origin, this document can be either a free sale certificate or registration certificate.
What are the requirements for researches items (Not for human use)?   1. LPO from the University.
2. Declaration of conformity with international quality and safety standards issued         by the manufacturer.


Medical Devices Permission to use FAQ:


 What are the required document to obtain the medical devices Permission to use?  

·       A list of medical devices should be submitted to medical_devices@nhra.bh  by all healthcare facilities with clear description of medical device name, model, manufacturer name, serial number Exal sheet templat of the list is available under post msrket surveillsnce tab. 

·       Valid NHRA Healthcare facility license.

·       Quality assurance certificate of the medical device. These certificates should be valid and with a scope matching with the function of the medical devices. (see verification guideline)

·       Invoice or OFOQ reference number should be provided for purchased medical devices since 2016.




Authorized Representative (AR) Registration FAQ:



FAQ
Answer
Who can register in NHRA?    All medical devices companies and importers should be registered in NHRA.
What are the benefits of being registered in NHRA?  

·        to be able to submit for medical device registration..

·        To be able to participate in tenders.

·        To be listed on NHRA website as a registered AR and avialble for puplic . 



Medical Device Registration FAQ:
FAQ
Answer
Only medical devices with HS Code regulated by NHRA should be registered?    No, All medical devices should be registered regardless of whether the HS code is regulated by NHRA or not.
How many medical devices can be registered in one submission?   According to the Bundling process. More information can be found in the medical devices registration
guideline.

 I cannot import Medical device unless it is registered in Bahrain?  

It is possible to import medical devices that are not yet registered until February 2026. For more information, 

please read circular No. 4 2021 found.

What risk class of medical devices can be registered?  

All medical devices should be registered regardless of their risk classification.

How much does it take to get the approval on ofoq?    It takes around 2-3 weeks starting from the date of submission.
 If I registered a medical device and obtained NHRA license, how can I obtain the approval for importation?    

For medical devices on OFOQ, please provide the NHRA license with the invoice and you will obtain the approval directly without providing all the required documents. 

مزيد من المعلومات

إحصائيات

عرض المزيد

روابط مهمة

عرض المزيد

تسجيلات الأحداث السابقة

عرض المزيد

شهادات ضمان الجودة

عرض المزيد

قائمة المهندسين لإجراء الصيانة للأجهزة الطبية

عرض المزيد

اسئلة شائعة

عرض المزيد

اشترك في نشرتنا الإخبارية

جميع الحقوق محفوظة ©، الهيئة الوطنية لتنظيم المهن والخدمات الصية، مملكة البحرين. 2025.