Health is a primary concern for everybody and the government. Health has a direct relationship with productivity. When a healthy person becomes sick, s/he needs standard, safe and effective medical care. To ensure proper medical care, good quality medicine and medical devices at affordable price are foremost. Keeping this it in mind, the Directorate General of Drug Administration (DGDA) Bangladesh formulated a guideline to regulate medical devices in Bangladesh which is approved by the Ministry of Health and Family Welfare (MoHFW).
In a bid to ensure the protection of health and safety in using medical devices, the DGDA has attempted to standardise the regulatory system of medical devices in the country through robust guidelines. The Registration Guidelines for Medical Device, Bangladesh 2015 has been formulated based on the guidelines of the Global Harmonisation Task Force (GHTF).
The newly framed guidelines categorised the medical devices based on the level of risk: ‘A’ for low risk like surgical retractors, tongue depressors, dressing gauge and bandage; ‘B’ for low - moderate risk like hypodermic needles and suction equipment; ‘C’ for moderate - high risk like lung ventilator and bone fixation plate and ‘D’ for high risk like heart valves and implantable defibrillator. The manufacturers have to follow international standards such as ISO, IEC and CE marking standard(s) or any other official standard(s).
The instruction has implemented conformity assessment procedures to ascertain manufacturer’s quality management system for the medical devices in accordance to ISO 13485:2003. The guidelines stipulate that conformity assessment procedures shall be the responsibility of the manufacturers and notified bodies for carrying out conformity assessment on the basis of the type of devices intended to be manufactured. All the rules that follow in order to establish the proper classification for the device should be taken into consideration.
Regarding specifications for Quality Management Systems, the DGDA is recommended to adopt International Standards like ISO 13485, Essential Principles of Safety and Performance of medical devices etc. Monographs of the United States and European Pharmacopoeia have also been included in the reference to harmonised standards for surgical sutures, bandages and a combination of drugs and devices etc.
Under the guidelines, all stakeholders have to mention the date of manufacture and expiry, device registration number and maximum retail price for locally manufactured or imported medical devices. The guidelines maintain the proper implementation of regulatory controls for manufacturing processes in order to safeguard the health and safety of patients and users.
Registration for all medical devices of class ‘B’, ‘C’ and ‘D’, as mentioned earlier has been made mandatory before they are imported or manufactured in the country. For medical devices which are to be imported or manufactured for the first time, the applicant has to apply for registration before such import or manufacture. The guidelines also affirm implementation of post-marketing surveillance systems, adverse incident reporting and vigilance activities, through which DGDA will monitor and take action against counterfeit and unregistered item as per drug act and drug ordinance.
It is expected that this guideline will enable DGDA and other stakeholders to ensure that Bangladeshi citizens can avail medical devices conforming to internationally acceptable standards of quality, safety and performance at affordable price.
The writer is the Director General, Directorate General of Drug Administration, Ministry of Health & Family Welfare of Bangladesh.