Medical Devices Registration in Bangladesh

Government Authority (DGDA)

In Bangladesh, the Directorate General of Drug Administration (DGDA) oversees medical devices registration. Operating under the Ministry of Health and Family Welfare, DGDA regulates the import, production, distribution, and sale of medical devices, emphasizing quality and safety standards. DGDA’s role is pivotal in ensuring the efficacy and reliability of medical devices through stringent oversight and country registrations.

Bangladesh Medical Device Regulations

In Bangladesh, the Bangladesh Drug and Cosmetics Act of 2023, enacted on September 18, serves as the cornerstone of regulatory provisions governing medical devices and pharmaceuticals. This legislation addresses crucial aspects such as manufacturing, importing, distributing, and selling medical devices, primarily focusing on ensuring adherence to quality and safety standards.

One significant requirement outlined in the Bangladesh Drug and Cosmetics Act is the necessity for medical device registration. Manufacturers and importers must obtain country registrations from the appropriate regulatory authorities. These registrations serve as official endorsements, affirming compliance with the regulatory framework and granting authorization for market entry and distribution.

Ensuring compliance with medical devices registration requirements is paramount for businesses in Bangladesh’s healthcare sector. By adhering to these regulations, companies demonstrate their commitment to upholding quality and safety standards, thereby fostering trust among consumers and stakeholders alike.

Medical Device Status

As of September 18, 2023, the Government of Bangladesh introduced the Drug and Cosmetics Act, 2023, outlining regulations for medical devices, IVD reagents, and software. This act expands the definition of medical devices, now encompassing software under drug regulations

According to the Drugs and Cosmetics Act, 2023, a medical device is defined as follows:

“Medical device” encompasses:

(a) Various devices such as instruments, apparatus, implements, machines, appliances, implants, diagnostic reagents (in vitro, in vivo, and silico reagents), software, or related materials. These are used either independently or in combination for specific purposes, including:

(i) Diagnosis, prevention, monitoring, treatment, or alleviation of diseases or disorders;

(ii) Diagnosis, monitoring, treatment, alleviation, or assistance for injuries or disabilities;

(iii) Investigation, replacement, modification, or support of anatomy or physiological processes;

(iv) Supporting or sustaining life;

(v) Conception control or medical device disinfection;

(vi) Providing information through examining and analyzing samples collected from human or animal bodies, unaffected by pharmacological, immunological, or metabolic actions.

(b) Additionally, any device or diagnostic reagent declared by the government, through notification in the Official Gazette, for this Act.

This comprehensive definition broadens the scope of medical devices under the regulatory purview, ensuring the safety and efficacy of products intended for use in Bangladesh. It underscores the importance of adherence to regulations for manufacturers seeking medical devices registration in Bangladesh.