The new article further describes in detail the regulatory approach to be followed when completing the procedures necessary for the importation of medical devices in line with the regulatory requirements set forth in Bahrain.
Table of Contents
The NHRA, Bahrain’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to importation requirements as set forth under the applicable legislation. The document provides an overview of the relevant legislation, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance with the relevant regulatory requirements.
At the same time, the authority reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Process of OFOQ Application
In particular, the document describes in detail the registration process to be followed by the interested parties.
For new applicants intending to use the OFOQ system, it is necessary to obtain a username and password. This can be done by submitting a form available on the official OFOQ website (http://www.ofoq.gov.bh) to the customs authority via email.
Once the username and password are received from the OFOQ support team, applicants can follow these steps to submit a new request:
- Access the OFOQ Platform: Open the website http://www.ofoq.gov.bh and click “OPEN WINDOW”.
- Login: Enter the provided username and password.
- Initiate a New License Request: Navigate to “Licensing”, right-click on “License”, and select “New”.
- Insert Ministry Code: Ensure the correct ministry code “2251” is inserted.
- Select License Type: Choose “single use only” as the license type.
- Enter Request Date: It is recommended to enter a validity period of one year to avoid expiry before the shipment arrives.
- Proceed to Item Details: Select “Item” at the bottom to move to the next page.
- Insert HS Code: Enter the HS code for the item(s). Ensure that the tariff description matches the imported item by clicking F3 on the Tariff heading box twice. For further assistance, contact the customs tariff department. If the most suitable description is not found, contact customs for product classification.
- Add Multiple HS Codes: If there is more than one HS code in the invoice for the same shipment, additional codes can be added using the icon at the top.
- Country of Origin: Insert the country-of-origin (CoO) in the country code box, ensuring that the selected code matches the invoice details.
- Enter Pricing Information: Select “PRICE” and enter the correct total price covering the HS code in the invoice without additional charges or discounts.
- Specify Item Type: Enter the correct item type number (registered or unregistered). For more information, the applicants should refer to Section 6 of the guidelines. Add any comments if needed.
- Attach Required Documents: Attach the medical device documents as specified in Section 4 of the guidelines.
- Store the Request: Save the request to complete this part of the process.
Fee Calculation and Payment
In addition to the above, applicants must calculate the types of medical devices listed in the invoice. Depending on whether the products are registered or unregistered, the correct number of types must be entered in the request.
A medical device “type” is defined by the following criteria:
- The same device.
- The same intended use.
- Matching brand names.
- Covered by the same Quality Assurance Certificate (DoC not applicable).
- Manufactured by the same physical manufacturer.
At the same time, exceptions could apply. In particular, certain items are considered separate types, such as:
- Consumables: Each is considered a different type (e.g., In Vitro Diagnostics (IVDs)).
- Spare Parts/Accessories: Each is considered a different type unless products share the same name or identification number (e.g., reference, model).
- Bundled Products: Bundled items (e.g., procedure packs) are considered one type.
The document also provides several examples illustrating the above approach, namely:
- A set of surgical instruments consisting of different sizes of scissors, sharing the same brand name, covered by the same CE certificate, and manufactured by the same entity, is considered one type.
- A set of surgical instruments consisting of different sizes of scissors and blades, sharing the same brand name and CE certificate but serving different purposes, is considered two types.
After completing the submission process and creating the application on the OFOQ system, store the application and email the authority to request a payment notice. The email should include:
- The License reference number.
- The Commercial Registration (CR) number.
- Applicant contact information:
- Company name.
- Phone number.
- Email address.
Once the payment request is processed, the applicant will receive a notification via email and phone, including a link to complete the payment through the FAWATEER system. After payment, the application status will change from “stored” to “requested”, and the NHRA will review and process the application.
Product Classification
Another important aspect addressed in the guidance relates to the classification of medical devices to be conducted in order to determine the regulatory requirements they should be subject to for ensuring their safety and proper performance.
For single-use medical devices, the OFOQ team will transfer the request to the classification department. Applicants must book an appointment through the “Microsoft Bookings” system to submit the required documents for product classification.
The submitted documents will be reviewed. If the product is determined to fall under medical device regulation, a classification letter will be issued, confirming that the product is classified as a medical device. For detailed information on the classification process, applicants should refer to the “Classification Guideline”.
Samples
The scope of the guidance also covers the aspects related to samples and the way they should be handled in the context of importation requirements.
According to the document, for the importation of surgical instruments or contact lenses, applicants must provide sealed samples to the NHRA upon the shipment’s arrival at the customs port. These samples will be checked and evaluated to ensure they meet international safety and quality standards and correspond with the provided documentation.
Applicants should submit the sealed samples along with the “Sample Form” and the required documents. Submission times are from 9:00 AM to 12:00 PM on any working day.
If the samples are approved, the OFOQ team will update the request status to approved in the OFOQ system. If rejected, a rejection letter will be issued, detailing the reasons, and the request will remain rejected in the OFOQ system. For more details, applicants should refer to the “Sample Form”.
Violations
Under the general rule, applicants are responsible for ensuring that all documents submitted to the NHRA are authentic and valid. Violations can occur if any documents are found to be invalid or if misleading information is provided.
Examples of violations include:
- Submitting invalid documents.
- Using a previously approved invoice to clear a new shipment.
- Adding HS codes or CoO not listed in the invoice.
- Providing falsified documents.
- Repeatedly making incorrect submissions without addressing the reasons for previous rejections.
Upon receiving a violation notice, applicants have one week to justify the error. If the justification is accepted, the violation will be dropped. If not, the violation will be recorded.
After multiple violations, the applicant’s company will receive a First Notice and will be required to provide an obligation letter signed by the CR owner, acknowledging the violations. This letter must be attached to every OFOQ application thereafter.
If the applicant continues to commit violations after receiving the First Notice, a Second Notice will be issued, leading to an official meeting with the CR owner to discuss corrective actions. Upon receiving a Third Notice, or if the same violations continue to occur, NHRA will take action through the SIJILAT system, where the CR activity will display the violation. Further details can be found in the “Violation Guideline”.
Glossary
The guidance also contains a “Glossary” section which provides additional terms and definitions used in the context of the document, such as:
- Manufacturer: The person or entity responsible for the design and manufacture of a medical device.
- Importer: The first person in the supply chain to make a medical device, manufactured in another jurisdiction, available in Bahrain.
- HS Code: The Harmonized System code used for product classification.
- FDA: The U.S. Food and Drug Administration, responsible for regulating food, drugs, and medical devices in the United States.
- SFDA: The Saudi Food and Drug Authority, which regulates food, drugs, and medical devices in Saudi Arabia.
- ISO 13485: An international standard outlining the requirements for a quality management system specific to the medical device industry.
- CE Mark: A certification mark that indicates conformity with health, safety, and environmental protection standards in the European Economic Area.
- Quality Assurance Certificate Verification: The process of verifying the validity of a quality assurance certificate.
- Notifying Body (Certifying Body): An entity that conducts conformity assessments under EU Directives and issues certificates to manufacturers whose products meet the required standards.
Conclusion
In summary, the present guidance provides a comprehensive overview of the steps and procedures for submitting medical device importation requests through the OFOQ system, including the responsibilities of applicants and the potential consequences of non-compliance with the regulations.
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