The article provides an overview of the regulatory requirements and procedures related to the importation of medical devices.
The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties involved regarding the regulatory approach suggested. Thus, the provisions described in the present draft guidance could be subject to changes due to new information becoming available to the authority.
The Agency will accept comments within two months from the date the document has been initially published. Once finalized, the document will provide additional recommendations and clarifications on the matter.
Due to their legal nature, guidance documents do not introduce any requirements themselves. The approach described therein should be taken into consideration by the medical device manufacturers or other parties engaged in operations with medical devices in the context of achieving and sustaining compliance with the applicable regulatory requirements set forth by the current legislation. Additionally, the Agency states that an alternative approach could be applied, provided such an approach has been approved by the authority in advance.
Thus, the present FDA guidance provides suggested recommendations for the design of feasibility and early feasibility clinical studies for certain medical devices. These recommendations are mostly based on existing clinical practice guidelines.
The National Health Regulatory Authority (NHRA), a Bahrain agency in the sphere of healthcare products, has published a guidance document dedicated to the online submission process of medical device importation approval. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers, importers, and other parties involved in the supply of medical devices intended to be marketed and used in the country.
First of all, the document provides the definitions of the most important terms and concepts used in the context of the guidance to assist with the interpretation of the underlying legislation. In particular, the authority defines a medical device based on its intended purpose, and also of 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 be better monitor and control all shipments accessing the Kingdom of Bahrain ports.
Under the general rule, any medical devices intended to be marketed and used in the country should be licensed by the regulating authority, otherwise, they would not be allowed to be imported and supplied to healthcare institutions or customers, while any operations with medical devices conducted without the appropriate approval granted by the authority are strictly prohibited.
The present guidance describes in detail the procedure to be followed when applying for importation pre-approval via the OFOQ system since according to the applicable legislation, all medical devices should have a valid online license and be subject to pre-approval.
Regulatory Requirements: Key Points
The guidance further provides a list of documents to be submitted to the authority to proceed with the application review. As explained by the authority, each of the documents should be submitted separately in PDF format and have the appropriate label. The language used should be either Arabic or English. The documents should be provided in a structured way ensuring easy navigation within the submission dossier.
According to the guidance, the main requirements to be followed are:
- Submission of the invoice including HS Code / Manufacturer Name & Country of Origin;
- NHRA medical devices registration license (or the documents as per the list below if the license is not available):
- Product quality documents (example: foreign government USFDA, CE), issued by a recognized certifying body;
- Quality Management System (ISO 13485);
- All certificates provided should be verified and a verification proof should be provided as a screenshot in the application;
- The catalog should contain the imported product code / Ref No. Of the product(s) mentioned in the invoice;
- The label of the medical device should include the name of the legal manufacturer.
Clinical Study Recommendations
According to the document, a clinical study should be carried out in order to assess and evaluate the safety and effectiveness of a medical device intended to be used for the purpose described herein. Such a study should be carried out under the Investigational Device Exemptions (IDE) framework. The Agency states that medical devices intended to therapeutically reduce glycemic levels for T2DM patients are associated with significant risks. Thus, the appropriate provisions on significant risk medical device studies should be applied. Should such an investigation take place in the US, it should also meet the requirements set forth under the current legislation in terms of institutional review boards and informed consent. However, clinical data deriving from clinical studies carried out abroad could be acceptable, provided it complies with the applicable regulatory requirements.
The present draft guidance highlights the most important aspects related to early feasibility studies, including the following:
1. Study objectives. As stated by the FDA, an early feasibility study is intended to evaluate the device design concept with respect to initial clinical safety and device functionality in a small number of subjects (generally fewer than ten initial subjects) when this information cannot be provided practically through additional nonclinical assessments or if appropriate nonclinical tests are unavailable. For instance, such an approach could be applied in the case of medical devices based on novel technologies. A party responsible for a clinical study (a sponsor) should take into consideration the provisions of this guidance when developing a study design. In general, a feasibility study is intended to collect initial safety and effectiveness data which would later be used as a basis for a clinical investigation. The Agency encourages sponsors to pay special attention to safety-related matters by gathering and analyzing information on adverse events associated with the medical device in question. From the effectiveness and performance standpoint, special attention should be paid to measuring glycated hemoglobin (HbA1c), while additional measures could be applied as well.
2. Study design. When determining the sample size, a sponsor shall take into consideration such factors as the current stage of medical device development, availability of data, and also the risks associated thereto. Under the general rule, the size of an early feasibility study should not exceed ten subjects. Consequently, the information to be collected by virtue of such a study would not be sufficient to completely assess the performance of the medical device subject to review. Nevertheless, performance-related aspects should also be taken into consideration. The Agency states that inaccurate or inefficient glycemic control will expose patients to additional risks. Thus, even if the data collected in the course of an early feasibility study is not sufficient for the assessment of all the aspects, it still provides a solid base for future clinical trials.
3. Study duration and follow-up. The studies described herein should include the appropriate follow-up period, which should be proportionate to the risks associated with the medical device subject to review. For instance, in the case of high-risk studies, such a period should exceed twelve months in order to assess the durability of effects. The protocol of the clinical study shall prescribe the way the information about adverse events should be collected and processed. Additionally, it should prescribe that the subjects be monitored until any and all adverse events are stabilized.
As it is stated by the NHRA, in certain cases, the authority may request additional documents to be submitted for the authority to have sufficient information to complete the review. These specific cases include, inter alia, the following ones:
- The legal and physical manufacturers are different legal entities. In such a case, it will be necessary to submit the Quality Assurance Certificate (CE) issued to the legal manufacturer by the respective national regulating authority in the sphere of medical devices; as well as the Quality Management System (ISO 13485) to be submitted by the physical manufacturer. Apart from this, it will be also necessary to prove a letter describing the relationship between the two companies. The authority additionally emphasizes that such a letter should be valid for at least 5 years.
- The authority reserves the right to request a Declaration of Conformity from the legal manufacturer, and ISO 13485 from the physical manufacturer in case of certain class I medical devices.
- In case the country’s database (the Online Verification Database) does not provide information regarding the way the device should be applied, including the application site or the intended use of the device, additional verification via email will be required.
- If the invoice is issued from a third party, it will be necessary to provide an authorization letter demonstrating the relationship between the two entities. As in the first case, an authorization letter should be valid for at least 5 years.
- In the case of contact lenses or surgical instruments, samples should be provided. However, as it is mentioned in the guidance, the said rule could be applied to any other devices at the authority’s sole discretion.
- For single-use medical devices, the appropriate classification letter should be provided to confirm that the product in question is a medical device and thus should be subject to regulation under the respective framework. Such a document could be issued by the NHRA MDR Department.
Apart from the specific aspects described hereinabove, the authority also provides an overview of the general rules to be considered when applying for importation approval and also highlights the key points to be considered in this respect. According to the guidance, the general rules include, inter alia, the following ones:
- Additional approval is required only for Class II and III medical devices that are listed on the authority’s website.
- All the activities related to obtaining approval for the importation should be undertaken by an authorized representative of the manufacturer acting on its behalf.
- To meet the eligibility criteria, an applicant entity should be duly incorporated for the purpose 4659 “Sale/Trade-in other machinery and equipment and parts – Medical Devices supplies and Related Parts”. As further clarified by the authority, the scope of activities should cover importation, exportation, and sale in the Bahrain market.
- The scope of entities eligible for applying for marketing approval includes not only importers but also healthcare institutions and clearance agents.
- The initial name and password should be provided to the applicant by the authority.
- The appropriate approval should be duly obtained by the procedure described hereinbefore the products in question would reach the country’s port.
- Should the product in question be already registered with the authority, it will be sufficient to send the confirmation of registration.
- The products imported under the said framework should be supplied to licensed healthcare institutions.
- It is not allowed to import used or refurbished medical devices.
- In certain cases, approval can be granted once the product reaches the port of destination.
In summary, the present NHRA provides a brief overview of the country’s regulatory requirements regarding the importation approval and highlights the key points associated thereto. The document also specifies the scope of information the authority expects the applicant to submit.
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