Ensure quality of medical devices for better healthcare
Health is the primary concern of people, and even the government. It is also directly linked to productivity. When a person becomes sick, he needs standard, safe and effective medical care. To ensure medical care, good quality medicine and medical devices at affordable prices are needed. Keeping this in mind, the Directorate General of Drug Administration (DGDA) and concerned experts have formulated a robust guideline to regulate medical devices in Bangladesh.
The Registration Guidelines for Medical Device, Bangladesh 2015 have been formulated based on the guidelines from the Global Harmonisation Task Force, which comprises of regulatory affairs experts to harmonise the regulation of medical devices internationally.
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 ventilators and bone fixation plate; and 'D' for high risk like heart valves and implantable defibrillator.
The guidelines comply with a set of essential principles so that supply of safe, effective and quality medical devices can be ensured.
The instruction has implemented conformity assessment procedures to ascertain manufacturer's quality management system for the medical devices in accordance with ISO 13485:2003.
The guidelines stipulate that conformity assessment procedures shall be the responsibility of 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.
Under the guidelines, locally manufactured or imported medical devices shall mention the date of manufacture and date of expiry. In case of medical devices imported to the country, the importer can carry out further labelling of the product for conforming to the labelling rules and maximum retail price of the individual item in the label before release for sale in the market.
The guidelines maintain the proper implementation of regulatory controls for manufacturing processes in order to safeguard the health and safety of patients, users and other persons. It aims to ensure that manufacturers of medical devices follow specified procedures during design, manufacture and marketing. The guidelines further suggest that regulatory controls should be proportional to the level of risk associated with a medical device. In general, the classification rules are intended to accommodate new technologies.
Registration for all medical devices of class B, C and D has been made mandatory before they are imported or manufactured in the country. Medical devices, already being imported or manufactured into the country, requires application immediately from the issue of this guideline.
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. A local authorised person of the manufacturer of the foreign supplier or authorised agent will apply to the DGDA for registration in prescribed form with a due amount of fees.
The guidelines also affirm implementation of post-marketing surveillance systems, adverse incident reporting and vigilance activities, through which DGDA will monitor and take action as per Drug Act 1940, Drug Control Ordinance 1982 and Drug Policy against counterfeit and unregistered item.
If DGDA considers that any product should be withdrawn from the market, or its placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, the authorities concerned may take any necessary measures.
All the relevant stakeholders are subjected to adhere to these guidelines for manufacture, import, distribution and sales of medical devices in Bangladesh. The decision to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations; or to withdraw devices from the market will state the exact grounds on which it is based.
Such decisions can be informed to the party concerned, who will at the same time be informed of the remedies available to him under the Drugs Act.
It is expected that this guideline will enable DGDA and other stakeholders to ensure that Bangladeshi citizens can avail themselves of medical devices conforming to internationally acceptable standards of quality, safety and performance at affordable price.
All stakeholders should do the following -- they have to submit relevant paper along with product for registration according to the checklist attached with the Medical Device Registration Guideline. Unregistered medical devices found in the market will be seized by mobile court and drug superintendent as per Drug Act 1940 and Drug Control Ordinance 1982. Instructions have been given to all healthcare institutions by the ministry not to purchase unregistered medical devices through tender.
Regulation is necessary to ensure safe, effective and good quality medical devices at affordable prices, which will ultimately help ensure quality health care. Every person concerned should come forward to work together and ensure quality health care.
The writer is the director general of Directorate General of Drug Administration.
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