The article highlights the key points related to the regulatory requirements for the online importation approval process.

The National Health Regulatory Authority (NHRA), Bahrain’s regulatory agency in the sphere of healthcare products, has published a draft guidance document dedicated to online medical device importation approval. Once finalized, the document will provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to assist medical device manufacturers and other parties involved with ensuring compliance with the requirements set forth under the existing regulatory framework. The authority also reserves the right to introduce changes to the present guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. 

In particular, the guidance describes the matters related to OFOQ – a web-based software developed by Customs Affairs – Ministry of Interior (MOI) allowing all the governmental sector to grant pre-approvals of shipments requests submitted by importers, on one page to better monitor and control all shipments accessing the Kingdom of Bahrain ports. 

Regulatory Background 

First of all, the authority emphasizes that in accordance with the existing legislation, the device and medical product must be used in healthcare facilities licensed by the Authority, and it is not permissible to manufacture or introduce any medical device and product to the Kingdom or put it in its markets or use it, except after registering with the Authority and obtaining written permission to market from Authority, and it is not permissible to transfer, resell, dispose of or export any medical device and product without the written approval of the Authority. The present draft guidance describes in detail the procedure to be followed when applying for a pre-approval of medical device importation by the device of the OFOQ system. In accordance with the changes introduced earlier in 2016, any and all products subject to regulation as medical devices should hold an online license cleared by customs. Hence, these products will be subject to pre-approval before being allowed for importation and supply. 


General Rules 

The authority further explains that its regulatory efforts are focused mostly on Class II and III medical devices under the applicable risk-based classification. An authorized representative of a foreign medical device manufacturer should be the party responsible for applying for pre-approval. Furthermore, in order to meet the eligibility criteria, an entity applying for an importation permit should have operations with medical devices included in its Commercial Registration. In particular, category 4659 “Sale/Trade in other machinery and equipment and parts – Medical Devices supplies and Related Parts” covers the importation and exportation of medical devices, as well as their distribution in the country. 

Before commencing the shipment, a party responsible for a medical device should submit a request via the said online system. The authority is entitled to request additional documents, apart from the ones described in the present guidance, should this be reasonably necessary to establish the safety, quality, and effectiveness of a medical device in question. It is also important to mention that any and all medical devices intended to be used only by healthcare professionals, to licensed healthcare institutions. The authority additionally emphasizes that the importation of used/refurbished medical devices is strictly prohibited. Apart from that, the authority reserves the right to request samples for further evaluation. 

According to the guidance, specific rules applies in the case of medical devices intended for research purpose only. As explained by the NHRA, such products should be approved by providing local purchased order (LPO) from the university and a Declaration of conformity to the international quality and safety standards issued by the manufacturer. 

It is also important to mention that the authority may partially approve the consignment, i.e. approval for non-compliant devices will be withheld – these products should not be placed on the market. 

Special requirements also apply with respect to cold chain products – in such a case, the applicant will have to provide the temperature data logger demonstrating that the respective temperature conditions were maintained within the whole period of transportation. Moreover, it is explicitly stated that the device cannot be placed on the market unless the data logger is approved by the authority. 

Should a medical device in question be intended for veterinary use, this should be clearly indicated in the documentation accompanying the device. 


List of Documents 

The guidance further outlines the list of documents to be submitted by an applicant requesting a pre-approval via the OFOQ system. According to the guidance, these documents include the following:

  1. Invoice including HS Code, Manufacturer Name, and Country of Origin;
  2. Authorized Representative certificate;
  3. NHRA medical devices registration license.

In case the medical device registration license is not available, the following should be provided:

  • Product quality documents;
  • Quality Management System (ISO 13485);
  • All certificates provided should be verified and verification proof should be provided as a screenshot in the application;
  • Catalog that should contain the imported product code / Ref No. of the product/s mentioned in the invoice;
  • Label of the medical device should include the name of the legal manufacturer.

In summary, the present NHRA guidance provides an overview of the current regulatory requirements related to the importation of medical devices intended to be marketed and used in the country. The document outlines the requirements to be fulfilled, as well as the procedure to be followed. 



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