The new article describes in detail the process of applying for importation approval for a medical device.
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The National Health Regulatory Authority (NHRA), a Bahrain’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to online medical device importation approval. The document provides an overview of the existing regulatory requirements, as well as additional clarifications and recommendations to be considered by the parties interested in placing medical devices on the country’s market. At the same time, provisions of the guidance and recommendations provided therein are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to assist in complying with the existing ones. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The document describes, inter alia, the procedure to be followed when submitting an online application for importation approval.
Application Process: Key Points
First of all, the authority states that in order to be able to commence the process, an interested party should have a username and password – it could be requested by sending the appropriate form via email.
When preparing the application, an interested party will have to fill in the following details:
- Ministry code;
- License type;
- Request date (the authority recommends indicating a 1-year range to make sure the permit will not expire before the shipment is completed);
- Code corresponding to the country of origin;
- Price per item and the overall amount of items to be shipped;
- Item category and type (e.g., “registered” or “unregistered”);
- Additional comments when necessary.
The application should be accompanied by the necessary documents, such as an invoice, catalog, CE certificate, and CE verification.
Fee Calculation and Payment
Under the general rule, the application for importation approval is subject to fee payable by the applicant. The said fee will depend on the types of medical devices being imported as per the respective invoice. In particular, the applicant shall provide the details about the medical devices to be imported and their regulatory status, indicating whether they are registered, or not. According to the guidance, a type is considered as one when a group of products meets all of the following criteria:
- Same device,
- Intended use,
- Matching brand names,
- Covered by the same Quality Assurance Certificate,
- Same physical manufacturer.
At the same time, there are specific exemptions to be taken into consideration, namely:
- Each consumable part will be considered as a different type;
- Each spare part/accessory will be considered as different type;
- Bundled products consider as one type (for example, this applies to procedure packs).
The authority also mentions that in the first two situations, the products could be considered as one type, provided they have the same name and/or identification number.
Once the steps described hereabove are completed in full, the applicant should save the application and submit it via email, requesting a payment notice to be issued. When making such a request, the applicant should provide the following information:
- The license reference number of the application;
- The commercial registration (CR);
- The applicant contacts information such as:
- Name,
- Phone number,
- Email.
In response, the applicant will receive a payment request with a special link to be used to perform the transaction. Once the said payment is completed, the general application status will be changed from “stored” to “requested”, meaning that from this point the authority will commence the review.
Product Classification
The document also provides additional information regarding the existing classification system for healthcare products allowed for marketing and use in the country. If the product being imported is a single-use medical device, the documentation and information necessary to determine the applicable class will be requested by the authority. According to the guidance, the submitted documents will be reviewed and studied, if the product falls under the medical device regulation, then a classification letter will be issued stating that the product is classified as a medical device. The authority further refers to a separate guidance dedicated to classification rules for additional information on this matter.
Samples
In certain cases, the applicant may be requested to provide sealed samples to the authority for subsequent review. This applies to such products as surgical instruments or contact lenses. The authority will conduct a rigorous assessment to ensure the samples comply with the applicable requirements and standards in terms of safety and quality and also meet the respective specifications. When submitting samples for review, the applicant should also provide the appropriate sample form together with the relevant documentation. Should the authority decide to reject the samples, the applicant will be notified in writing, and the grounds for such a decision taken by the authority will be communicated to the applicant.
Violations
Another important topic addressed in the guidance relates to potential violations in the sphere of importation of medical devices. In particular, the authority explicitly states that the applicant is responsible for ensuring the authenticity and validity of any and all documents included in the submission. The document also provides a list of potential violations which includes, inter alia, the following ones:
- Invalid documents;
- Using previously approved invoice to clear new shipment;
- Adding HS code and/or CoO not existing in the new invoice;
- Providing misleading information;
- Falsified documents;
- Repetition of wrong submission without complying with the rejection reason of previous application.
In accordance with the procedure described in the guidance, the applicant will have one week starting from the date the violation notice was communicated to provide the appropriate justification. Should the applicant fail to provide a justification the authority will find acceptable, the violation will be registered. Subsequent violations may result in regulatory actions taken by the authority against the applicant.
In summary, the present guidance describes in detail the application process and also highlights other important aspects related to the importation approval, including the calculation of fees, product classification, provision of samples, and violations. The document provides additional clarifications regarding each of the abovementioned matters and outlines the key points to be considered by applicants in order to ensure compliance with the respective requirements.
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