What are the products that are eligible for the Bangladesh DGDA certification for medical devices?

Mondo International Updated on 2024-03-06

Medical Device Bangladesh DGDA certification is applicable to many types of medical device products, including but not limited to the following categories:

Diagnostic equipment

Medical ultrasound equipment, X-ray equipment, nuclear magnetic resonance equipment, CT scanning equipment and other equipment used for medical imaging diagnosis.

Blood glucose meters, blood pressure monitors, thermometers, electrocardiographs and other equipment used for physiological parameter monitoring and diagnosis.

Equipment

Medical laser equipment, radiological equipment, electrosurgical equipment, medical ultrasonic knife and other equipment used for ** diseases.

Ventilators, cardiac defibrillators, defibrillators and other equipment used for first aid and **.

Surgical instruments

Surgical knives, forceps, scissors, needles, needles, needles, and other instruments used in surgical procedures.

Anesthesia instruments, surgical lights, operating tables, and other equipment used in operating rooms.

Equipment

Traction equipment, orthoses, walkers, wheelchairs, and other equipment used for *** and assisted mobility.

Orthotics, prostheses, prosthetics and other equipment for people with physical disabilities**.

Oral medical devices

Dental diagnosis and treatment equipment, oral equipment, oral hygiene equipment and other equipment used for oral medical treatment.

Dental surgical instruments, scalers, dental photography equipment, etc.

Medical assistive devices

Medical gauze, dressings, urinary catheters, gastric tubes, endotracheal intubations and other assistive devices used for medical care.

Personal protective equipment such as medical gloves, masks, protective glasses, etc.

Other medical devices

Medical syringes, infusion sets, infusion pumps, infusion bags and other instruments used for medical injections and infusions.

Medical reagents, laboratory equipment, disinfection equipment, etc.

In Bangladesh, all medical device products sold and used need to be certified by the Bangladesh Drug Administration (DGDA). Therefore, when enterprises enter the Bangladesh market to sell medical device products, whether they are produced domestically or imported, they need to ensure that the products meet the certification requirements of the Bangladesh DGDA and obtain the corresponding certification certificates. In this way, we can ensure the legality, safety and quality reliability of products, protect the health and interests of consumers, and improve the competitiveness and market share of products in the Bangladesh market.

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