Section 1 · Introduction

1. Introduction Medical devices registration is one of the services in the pre-market phase of the medical devices regulation that is recommended by the WHO (World health organization). Medical devices registration facilitates the importation of devices by minimizing the number of required documents and enhancing the level of traceability of devices in the kingdom. It also enables end-users to easily contact the local authorized representatives. With reference to Decision (48) 2020, Article (5) “The Authority establishes an electronic system of the registration of medical devices and products and their facilities, in which all data relating to the device and the establishment, in particular the name of the device, serial number, country of origin and its shelf life, shall be recorded as follows: • Inventory and management of the information required to register medical devices and products and their facilities. • A visualization of the market size for medical devices and products in the Kingdom. • Provide information on facilities engaged in the manufacture, distributors or importers medical devices and products in the Kingdom. • Provide information on medical devices and products that will be marketed or already used in the Kingdom.” Registration of medical devices is done after ensuring the compliance of medical devices with international standards of quality and safety. This process was adapted from worldwide recognized regulatory authorities’ such as SFDA, FDA, MHRA, and TGA in order to be harmonized with the global regulations of medical devices. These regulations were then customized to fit with the size of the kingdom of Bahrain market.

Section 2 · General Rules

2. General Rules 1. Only registered authorized representative can apply for medical device registration. 2. All medium and high-risk devices must be registered (Class IIa, IIb, and III) / IVD (Class B, C, D). Low risk devices are optional. 3. All registered medical devices will be published along with their authorized representative on NHRA website. 4. All healthcare facilities will be instructed to purchase only registered medical devices to ensure the patient safety. 5. Registration is not linked to HS codes being regulated by NHRA or not. 6. Registrations fees are applied. Please refer to “Medical Devices Fees Guideline”. 7. Classification criteria must be fulfilled (If applicable) before submitting for registration (see classification guideline). 8. All required official letters/documents should be signed and stamped by the issuer (electronic signature and electronic stamp are accepted). 9. Medical devices purchasing and marketing prices required in the registration form will be confidential and will be used for study purposes only. 10. Accessories/spare parts cannot be registered. In importation, it is mandatory to provide evidence from the legal manufacturer that the product is an accessory, or a spare part related to the main registered device. For example, official letter from the legal manufacturer or a catalogue. 11. The timeframe of registration application review is 20 working days. Fast track (Through third party services) is also available with a time frame of 10 working days. 12. NHRA may ask for additional documents as part of the review.

Section 3 · Process of Submission

3. Process of Submission In order to submit a medical device registration application, applicants should book an appointment through “Ajheza” system and submit all required documents at the booked date and time on the system. The review process timeframe is 20 working days. If all requirements are fulfilled, a registration certificate will be issued with a validity of one year. However, in case not all requirements are fulfilled, the application will be reverted back to the applicant with the recommended action to be taken. The applicant will have two more attempts to submit the application (needs to book a new appointment) in order to fulfill the remaining requirements without repaying the application fees. If the application still does not fulfill all the requirements in the third submission, it will be rejected and the applicant will need to pay the application fees again in order to resubmit the application.

Section 4 · Listing

4. Listing All registered medical devices authorized representatives (AR) must list all medical devices that have been imported or are intended to be imported in the future. Only listed medical devices can be applied for medical device registration. To list the medical devices, the applicant needs to fill the following sheet and submit it to medical_devices@nhra.bh. https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/department s/MDR/Lists/MDR_Form_Medical%20devices%20listing.xlsx Note: Listing should be submitted (including all medical devices) prior to submitting medical device registration applications and it should not be submitted as part of the medical device registration application.

Section 5 · Requirements of Medical Devices Registration

5. Requirements of Medical Devices Registration Unconditional Requirements: 1) Technical Details such as IFU, leaflet or user manual. 2) Artwork i.e., Label of the Medical Device. Should include the Name and a device Identification number (catalogue No, reference No, Model No) and legal manufacturer name with address. (For Similar medical devices bundling group applications with more than 3 medical devices, minimum of 3 artworks should be submitted. For family and IVD bundling group cases where providing all medical device artworks is not feasible, applicants can contact NHRA through email for recommendation). 3) Agreement or Authorization letter issued by the legal manufacturer to the Authorized Representative for the registration and distribution of the applied Medical Device(s) in the Kingdom of Bahrain. 4) Relationship Letter issued by the legal manufacturer stating its relationship with the physical manufacturers and invoice issuer regarding the medical device(s). Full addresses must be mentioned. 5) Quality Management System Certificate (QMS) - ISO 13485 for the Physical manufacturer with the address matching requirement 4 along with verification evidence (See Quality Assurance Certificates and Verification Process Guideline for further clarification.). 6) Quality Assurance Certificate (QAC) - CE directives 93/42/EEC, 2017/745, 98/79/EC, 2017/746 or FDA Certificate to Foreign Government (CFG) for the Legal manufacturer with the address matching the artwork along with verification evidence (See Quality Assurance Certificates and Verification Process Guideline for further clarification.). Not applicable for class I non-sterile and Class A/others IVD. 7) Declaration of Conformity (DOC) as per EU regulations issued by the legal manufacturer. GMDN code can be included in the DOC or in a separate official letter. Conditional Requirements: 1) For class III medical devices as well as class D IVD’s, an EC Design examination certificate or an FDA Certificate to Foreign Government (CFG) for the legal manufacturer is required along with verification evidence (See Quality Assurance Certificates and Verification Process Guideline for further clarification.). This document needs to be submitted for class IIB medical devices if available. 2) If the medical device contains animal tissues/derivatives, a letter issued by the legal manufacturer stating that the product is free from porcine derivatives is required (Not applicable for in Vitro Diagnostic (IVD) Medical devices). 3) In some cases, mainly for borderline products, it might be requested to fulfill the classification criteria where NHRA classification letter issued from MDR department should be provided (See Medical Device Classification Process Guideline for further clarification). Additional requirements may be requested depending on the device/case.

Section 6 · Software Registration

6. Software Registration “Software as a Medical Device” is defined as a software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. If the software is classified as a medical device, then it can be registered in NHRA with the same requirements of medical devices registration given in Section (5).

Section 7 · Research use only

7. Research use only Research Use Only (RUO) products are instruments, apparatus, appliances, materials, or other articles, including software, which are intended to be used for research purposes, without any medical objective. (Not for Clinical use, Not for Diagnosis, or treatment). These products are not classified as medical devices and therefore, not required to be registered in NHRA.

Section 8 · Appeal

8. Appeal If the rejection/reverted back reason can be justified without submitting new documents (that are already stated in the requirements), applicants have 10 working days to submit for appeal and provide justification.

Section 9 · License Variation

9. License Variation The medical device license can be amended during the validity period according to the type of variations done in device details which can be: ➢ Minor Variation: Any modification that does not affect safety or performance of a medical device. Examples: • Renewal of any certificate or official letter. • Changes made in the artwork / label of the medical device. • Changes in the instruction for use. • Changes made to the authorized representative details. • Change in medical device name or product identifier (Model/reference). • Adding devices to a registration license in case of color, package quantity, or volume variant. Not applicable for IVDs. ➢ Major Variation: Any modification that does affect the safety or performance of the medical device. Examples: • Changing the legal or physical manufacturer or changing the address. • Changes made in the manufacturing process of the medical device. • Changing design or detailed specification of the medical device. • Change in risk classification of the medical device. Minor Variation Required documents: 1) Letter of variation from the legal manufacturer regarding the variation with a statement that the changes do not affect the safety and quality of the medical device. The letter should also state the reason behind the variation and whether the notified body has been informed regarding the change in addition to if there are any impacts on the quality documents. 2) Updated and varied version of the document. For example, if the variation is in the artwork, the updated artwork needs to be provided. 3) Based on the variation, other requirements may be requested. General directions: • No need to submit for variation when it is related to price. • Validity of the certificate will not change and will remain the same. • For software registration, Submission of variation for each new version is required. if the software updates don’t affect the main function, then it will be considered as a minor variation, but if the updates affect the intended use of the software, then it will be considered as a major variation. • Timeline of reporting for variation: NHRA should be informed instantly by email (without the need to take an appointment) from the time of receiving a change notification from the manufacturer. • Timeframe of NHRA review is 20 working days. Variation application outcome: Minor Variation: If a variation application is accepted, an approval letter will be issued from NHRA. In case not all requirements are fulfilled, the application will be reverted back to the applicant with the reasons. Major Variation: applicant should submit for new medical device registration application. Please note that the approval of the submitted variation should be finalized prior to the importation of the amended medical device.

Section 10 · Medical Devices Registration License Renewal

10. Medical Devices Registration License Renewal Applicants should submit for medical device registration renewal at max 1 month before its expiry date. Unconditional Requirements: 1) Changes letter issued from the legal manufacturer stating whether there are changes/updates done or not from the time of last registration affecting the medical device/s or any of the documents previously submitted. If there are changes, details need to be provided with a statement that these changes do not affect the safety and quality of the medical device. 2) List of countries the medical device has been marketed in, issued by the Legal manufacturer. 3) List of End-users issued by the Authorized Representative in case the medical device exists in Bahrain market. 4) Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country. 5) If the device has been marketed in Bahrain for a minimum of 3 years, an official letter from the legal manufacturer mentioning Bahrain market field safety notice records for the past 3 years is required. If the device has not been marketed in Bahrain for a minimum of 3 years, an official letter from the legal manufacturer mentioning worldwide and Bahrain market field safety notice records for the past 3 years is required. Remark: If there are no field safety notice records, the above points still apply and an official letter from the legal manufacturer needs to be provided stating that there are no field safety notice records related to the devices. 6) Updated verification of quality documents. Conditional Requirements: 1) If there are field safety notice records affecting Bahrain market, an official letter from NHRA medical devices post market department that each record is closed is required. If there are worldwide field safety notice records, an official letter from the legal manufacturer stating the actions taken regarding each record and whether it was closed is required. 2) If any of the previously submitted documents expired or amended, updated documents need to be provided. For Certificates issued before October 2020: All documents required in “Section 5 and 10” of this guideline should be submitted.

Section 11 · Transferring Local Representative

11. Transferring Local Representative Transferring agency from an authorized representative to another one will be considered as a minor variation and the registration of the medical device will not be affected as long as the registration certificate is valid, the below required documents should be provided: 1. Official letter issued from the new authorized representative confirming taking full responsibility of the medical device and that full handover for the device data have been transferred including.: Distribution records, Adverse events, FSN records, and Maintenance records (if any). 2. Authorization letter issued from the manufacturer to the new authorized representative.

Section 12 · Manufacturer Acquisition

12. Manufacturer Acquisition An acquisition is when one manufacturer purchases most or all of another manufacturer's shares to gain control of that company. In this case, manufacturer acquisition is considered a variation and based on provided documents NHRA will determine whether it is a minor or major variation. Required documents are: • New / old artwork (highlighting differences) • Agreement / Letter of acquisition signed and stamped by both manufacturers stating the roles and responsibilities of each entity and explaining the impact of acquisition on the medical device in the market. • Official declaration issued from new manufacturer stating that all acquisition changes has been clearly declared to NHRA with supportive documents. • Quality certificates (QAC, QMS) for new manufacturer. • Free Sale Certificate. • List of affected medical devices by the acquisition in Bahrain market. • Technical Details.

Section 13 · Registration Cancellation Reasons

13. Registration Cancellation Reasons 1.14.The QualityProcess13. Bundling Assurance Registration Certificate/Quality Management Cancellation System is expired (not Reasons renewed) or invalid (no longer available on notifying body website) with no valid justification from the Authorized Representative. 2. InBundling 14. Process13. case of major Registration Cancellation Reasons variation. 3. The medical device is subjected to a recall or caused a serious adverse event. 4.14.The Bundling Process13. authorized Registration representative did notCancellation Reasonsrenewal. apply for registration 5. CR expired/deactivated due to violations causing a delay in renewal application. 6. Authorization agreement between the authorized representative and the legal manufacturer is cancelled or no longer valid. 7. Relationship letter gets cancelled for reasons such changing the physical manufacturer and NHRA have not been informed for variation. 8. Any other reasons determined by the national healthcare regulatory authority. The following flowchart can simplify the process of Medical Device Registration:

Section 14 · Bundling Process

14. Bundling Process 14. Bundling Bundling Process multiple devices in one application. The Bundling process is is submitting clarified in the flow chart below, and it is divided into five bundling groups as follows: 1. 14. Similar Medical Bundling Devices. Process 2. Medical Devices Family. 14. Bundling Process 3. Medical Devices System(s). 4. Medical Devices Procedure Pack. 5. IVD (In-Vitro Diagnostic). 1. Similar Medical Devices A medical device that could have different models including color, quantity, range of size, number of units…. etc. For example, contact lenses. Medical device that have more than one model may be bundled/grouped within one application only if they have: Same Same Legal Intended use manufacturer Same risk Same Brand class Brand Name 2. Medical Devices Family A group of medical devices that are made by the same manufacturer, have the same common intended use/purpose and the same risk classification and only differ in features. Differences in features may include, material, structural characteristic, design, patient groups, energy source, purpose, brand name, model name or device description, area of application, additional function, and additional secondary intended use/purpose. Medical devices that have different features may be bundled/grouped within one application only if they have: Same Legal Same Intended manufacturer use Same risk class 3. Medical Devices System(s) Means a device comprises of a number of medical devices, which can be combined or operated in combination to achieve a common intended use/purpose. For example, an endoscopy tower which consists of: • Endoscopy camera • Monitor • Scopes • Surgical tools medical devices with different intended use/purpose may be bundled/grouped if they fulfill the below criteria: Same Legal Compatible when used as medical manufacturer devices. Sold under a medical devices Intended to be used in system name; or the labeling, combination to instruction for use (IFU), complete a common brochures or catalogues for intended use/purpose. each constituent component is intended for use/purpose with the system. 4. Medical Devices Procedure Pack A collection of two or more medical devices, assembled together to perform a certain procedure as one package by a manufacturer. Packs, sets or kits may be bundled/grouped within one application only if they have conformity assessment under article 12 of EU MDD 93/42/EEC. Same Legal manufacturer for the Common intended use Packs Grouped/ bundled based 50 do not exceed 50 items per on specialty. application 5. IVD (In-Vitro Diagnostic) Registration of IVDs can be bundled in one application if they are from the same manufacturer, with same risk classification, have same intended use and under the same original approval (QAC). The maximum number of devices per application is 50. 15. Glossary 14. Glossary No. Terminology Definition 15.Annex15. Glossary Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, 14. Glossary for one or more of the specific medical purpose(s) of: 1. Diagnosis, prevention, monitoring, treatment, or alleviation of disease. 16. Annex15. Glossary 2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury. 3. Investigation, replacement, modification, or support of 14. Glossary the anatomy or of a physiological process. 1 Medical Device 4. Supporting or sustaining life. 5. Control of conception. 15.Annex15. Glossary 6. Disinfection of medical devices. 7. Providing information by means of in vitro examination 14. Glossary of specimens derived from the human body. And does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. any Medical Device which is a reagent, reagent product, calibrator, control material, kit, instrument apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing IVD (In-Vitro 2 information: Diagnostic): • Concerning a physiological or pathological state, or • Concerning a congenital abnormality, or • To determine the safety and compatibility with potential recipients, or • To monitor therapeutic measures. Any natural or legal person with responsibility for design and manufacture of a medical device with the intention of making it available for use, under his name; whether or not such a medical device is designed and/or manufactured 3 Manufacturer by that person himself or on his behalf by another person. No. Terminology Definition International Organization for Standardization Quality management systems required for regulatory purposes is an (ISO) standard published for the first time in 1996; it ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical 5 devices. Conformity European which literately means “European Conformity”. The term initially used was “EC Mark” and it was officially replaced by “CE Marking” in the Directive 6 CE mark 93/68/EEC in 1993, declaring that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations. Means to check the validity of the quality assurance certificate by contacting the notifying body either by sending an email (6 Quality Assurance Certificate months validity) or online through the website of the notifying Verification body. 7 (Refer to Verification guideline on NHRA website) Report issued from the notifying body to ensure the manufacturer process and documentation in addition to the Audit Report corrective action taken in case of non-compliance is as per 8 international standards. Regional authorized distributor who is responsible of issuing Authorized distributor 9 invoices to Bahrain authorized representative. The role of the certified Body is to conduct a conformity assessment under the relevant EU Directives. The conformity assessment usually involves an audit of the manufacturer’s quality system and depending upon the particular classification of the device, a review of the relevant technical documentation Certifying Body provided by the manufacturer in support of the safety and 10 performance claims for the device. Once the certified Body has determined a manufacturer has conformed to the relevant assessment criteria, it issues a certificate to show that the products assessed meet the requirements. A firm registered by NHRA, authorized by the manufacturer 11 Authorized Representative through an official document; declaring them as their representing entity in the kingdom of Bahrain. No. Terminology Definition The Harmonized Commodity Description and Coding System generally referred to as "Harmonized System" or simply "HS" is a multipurpose international product nomenclature developed by the HS code World Customs Organization (WCO). 12 The Harmonized Commodity Description and Coding System (HS) is broad and is not structured for medical devices field. Food and Drug Administration, it is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco, dietary FDA supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting 13 devices (ERED), cosmetics, animal foods & feed[4] and veterinary products. Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, 14 Reference countries Ireland, Denmark, New Zealand, France, Holland, Belgium. MDD: Class I-Non-sterile. MDR: Class I, Im (with a measuring function), Ir (Reusable Low risk medical surgical instruments), Is (Sterile). 15 devices IVDD: Other/general IVD. IVDR: Class A. MDD and MDR: Class IIa and Class IIb. Medium risk IVDD: Annex II list B. 16 medical devices IVDR: Class B and Class C. MDD and MDR: Class III. High risk medical IVDD: Annex II list A. 17 devices IVDR: Class D. Medical Device Directive 93/42/EEC. 18 MDD Medical Device Regulation 2017/746. 19 MDR In Vitro Diagnostic Directive 98/79/EC. 20 IVDD In Vitro Diagnostic Devices Regulation 2017/746 21 IVDR Date of market The date that the device entered the kingdom of Bahrain. 22 entry 16. Annex Please visit NHRA website www.nhra.bh for more information about Ajheza system and Fast Track15.Annex submission route. 15.Annex 15.Annex 16. Annex 15.Annex 15.Annex 15.Annex