Medical Device Regulation in Kingdom of Bahrain will transform the Healthcare market.

Did you know that the global device market currently stands close to $500 billion? The Middle East medical devices market size is expected to reach USD 31.6 billion by 2025, which is almost close to 17% of the global market share.

In recent times, the Middle East medical device market has witnessed rising competitive pressure as a result of high demand and low supply ratio. Major developments are being witnessed in terms of regulatory structures as well, with an agenda to provide monetary benefits to the civilians and improve the overall lifestyle of the people.

Quality Assurance and Regulatory Affairs play a critical role in outlining and streaming medical devices and products. Medical devices and pharmaceutical products are designed and developed following standardized manufacturing practices, laboratory practices, etc. Regulation and registration of medical devices are imperative for the efficiency of medical procedures and, to an extent, the economy’s growth.

In Bahrain, while the Pharmaceutical Products Regulation Department (PPR) of the National Health Regulatory Authority (NHRA) ensures consistency with current medical and scientific knowledge, quality, safety, and efficacy of pharmaceutical products, it’s the medical device market that is still developing. There are reforms being introduced to ensure the medical device is sturdy and sustainable.

At Professional Regulatory Affairs (PRA), we continue to bring workable solutions to regulatory problems and educate people about various development programs and regulatory requirements. Our series of podcasts under the title of REG VOICE, brings to light the medical device and health care sector issues and suggest ways to resolve them.

In this episode, we had the pleasure of speaking to Engineer Nada al Sayegh, who is an ISO13485 certified auditor and consulting advising engineer for safety and national health care regulatory authority. Her vast pool of knowledge and proficiency has helped bring about reforms in healthcare quality, safety, and clinical engineering. She envisions introducing radical medical regulations and reforms in the Kingdom of Bahrain to help improve the positioning of the nation’s medical and healthcare systems.

Through our discussion, we highlighted the necessity of bringing about reforms and regulations in the medical device market in the Kingdom of Bahrain. Even though the registration enforcement began in the Kingdom of Bahrain in 2015, it wasn’t enforced effectively due to a lack of legislation. However, since the need for a regulated and advanced medical and health care market is the need of the hour, it becomes vital to ensure seamless and successful registration of medical devices and products.

Before a medical device can be sold in Bahrain, an application must be submitted to the NHRA. This must contain all the necessary data supporting its quality, safety, and efficacy. To accomplish this objective and to bring about effective and regulated functioning of the medical and health care market, the following points were discussed:

-    Medical devices need to be registered by a legal and authorized representative. All medical devices should be registered regardless of whether the Harmonized System (HS) code is regulated by NHRA or not.

-    Before the importation of any products, it needs to be registered with the relevant authority. A license with the commercial department should suffice when importing products. Bahrain is an open market. A valid customs registration number allows you to import medical devices as per NHRA rules and regulations.

-    These authorized representatives or legal agents need to be registered with the NHRA.

-    NHRA is starting to regulate medical devices type II and III, and they are excluding type one devices. All devices and products will undergo a classification, and a detailed list of classified products and categories is available on the NHRA website.

-    The products will need to undergo a classification process to know if it will fall under the medical device’s category or other category. Once the classification is done, according to the result, the listing and registration will be applicable.

-    The registration of the product manufacturer and the registration of the product can happen simultaneously and will help in saving time as in some other countries, the company is required to finish the manufacturer registration process first, in order to start the product registration.

-    The certificate of registration will be valid for one year and will eventually be extended to 5 years following the duration of other GCC countries.

-    Registration certificates of other GCC will be considered valid and help expedite your Bahrain registration process as you still require to register here.

-    The registration process is indeed a cumbersome one and NHRA is doing its best to streamline all operations. Due to the huge no. of applications for medical devices classifications and registration, NHRA has also outsourced Medspero to help expedite the process.

-    Current timeline for registration to be completed is considered to be four weeks, but the registration of some specific products can take up to 3 months.

-    The registration of Hyaluronic acid fillers is also considered under medical devices.

-    Current focus is centred around the registration of category two and category three devices.

-    IVD and Laboratory devices fall under the category of medical devices and would require registration.

-    There are separate classifications for items like insect repellents. There exists a separate category for medicinal device spare parts as well. Different classifications help make the registration process easy.

- To change the ownership or authority of a legal representative or distributor, relevant details would be required, and it would need to undergo a variation of medical device registration.

-    If an international company wants to start marketing their product in Bahrain, they need to have a registered agent or representative. Importation of devices would require approvals per HS code.

Eng. Nada assured us that while all these regulations and reforms may be new and challenging to comply with initially, they are working to streamline and expedite the process for everyone’s well-being. At PRA, we are committed to bringing you knowledge and solutions regarding the regulatory and pharmaceutical market to ensure all interrelated departments succeed and prosper. We will soon be bringing to you our next REG Voice Podcast, stay tuned to know about the latest developments and garner more information.