Bahrain introduces new regulations on medical devices and products

In a step toward enhancing the safety and quality of healthcare in Bahrain, the Supreme Health Council has introduced new regulations governing medical devices and products. Announced by Lieutenant General Dr. Shaikh Mohammed bin Abdullah Al Khalifa, the regulations aim to tighten oversight, ensure compliance, and safeguard public health.

These changes affect manufacturers, marketers, and health facilities, setting a new standard for the importation, marketing, and usage of medical equipment.

How does it work?

The new regulations require all establishments involved in medical devices or products to obtain a license from the National Health Regulatory Authority (NHRA). This applies to activities ranging from marketing contact lenses and cosmetic lasers to the manufacturing and importation of medical products.

For medical devices to be legally marketed or used, they must first be registered with the NHRA, meet specific quality standards, and gain approval from recognized regulatory bodies such as the FDA (USA), TGA (Australia), and SFDA (Saudi Arabia). These reference-country certifications ensure that only high-quality, safe products enter the Bahraini market. Additionally, establishments must adhere to strict storage and transportation guidelines based on manufacturer instructions, further promoting safety and efficacy.

Low-risk home devices like digital thermometers and blood pressure monitors are exempt from marketing authorization but must still comply with basic safety standards.

Why does it matter?

This move is pivotal for strengthening Bahrain's healthcare system by preventing the circulation of unregulated or substandard medical products. The decision safeguards patients, promotes transparency, and aligns Bahrain with international healthcare standards. Also, the new regulations reflect Bahrain's commitment to enhancing health safety and ensuring only approved medical devices are available to the public.

The emphasis on compliance, proper licensing, and oversight protects consumers from potentially harmful products and supports a more reliable healthcare infrastructure. For manufacturers and importers, these regulations also provide clarity and a level playing field for market entry.

The context

Bahrain's healthcare sector has witnessed rapid growth, with an increasing demand for advanced medical technologies. However, the lack of stringent oversight in the past posed risks to consumer safety and market integrity. By adopting these comprehensive regulations, the Supreme Health Council addresses gaps in quality assurance while harmonizing with international best practices.

The focus on using reference countries for product registration ensures that only globally vetted devices and products are permitted. For instance, devices must have prior approval from agencies such as the MHRA (UK) or Swissmedic (Switzerland) before they are marketed in Bahrain. This alignment with established standards elevates local healthcare and boosts confidence in Bahrain's regulatory framework.

In summary, Bahrain's updated regulations on medical devices mark a new era of accountability and quality assurance — benefitting both consumers and the healthcare industry at large.