Bangladesh has recently published updated requirements for the manufacturing, importation, distribution and sales of medical devices on their domestic market.
The Scope of the Guidelines
At the moment, medical device circulation guidelines are regulated under the Drug Act 1940, Drug (Control) Ordinance 1982 and under the other regulations described. First of all, the document provides a list of definitions, including “medical device”, “manufacturer”, “accessory to medical device”, “active medical device”, “active therapeutic device” and “active device intended for diagnosis”. The document also contains a detailed explanation of the classification of combination medical devices. According to the rules, medical devices are subject to 4 classes of risk-based categorization: A, B, C and D. It is also stated that in certain cases the international classification could be accepted by the regulating authority. The rules applicable to classification also cover aspects like intended use and possible impact on the patient’s body. Another important criterion implemented by the classification rules is the duration of use, that could be:
– Transient (up to 60 min.),
– Short term (from 60 min. to 30 days),
– Long term (if the duration of use exceeds 30 days).
It is also necessary to mention that the duration of use covers the whole period, despite any interruptions or removals necessary, that one uses the device. It also constitutes the whole period until the expiration of which the device should be replaced by another.
Classification rules provide additional criteria applicable to invasive medical devices (including body orifice or surgically invasive devices) and reusable surgical instruments.
The guideline also provides a detailed description of procedures related to placing the device on the market including both domestic and foreign medical devices. Under these requirements, Class B, C and D medical devices are subject to obligatory registration. At the same time, in vitro diagnostic medical devices fall outside the scope of the classification rules provided as an annex to the guideline described.
Requirements: Placing a Device on the Market
The new document contains detailed provisions regulating the way new devices should be placed on the market. It is stated that safety principles implemented by the guideline are aimed to ensure the highest protection of a patient’s health. For this purpose, the conformity assessment procedures should be performed to assess compliance with all applicable requirements including ISO, IEC, Essential Principles of Safety and Performance of medical devices, and other standards recognized by the national regulating authority.
According to the regulation, the following requirements should be applied:
- Due to the lowest level of risk, conformity assessment of Class A medical devices should be performed by the manufacturer itself without the engagement of the notified body. The manufacturers are also exempt from the obligations of obtaining the license. For this class of devices, the notification procedure should be applied – the manufacturer must notify the regulating authority by submitting the Declaration of Conformity.
- Devices of Classes B, C, and D are subject to obligatory certification (including the quality management system), and Class D medical devices are also subject to the certification of design. To fulfill the obligations the manufacturer or other party involved (e.g. importer) should apply for registration by submitting an application to the regulating authority accompanied by the documents required. The manufacturer should also notify the authority on clinical investigations regarding such devices and to provide additional explanations if an investigation has been suspended prior to the pre-defined date.
The aforementioned devices are also subject to post-marketing surveillance – the manufacturer should monitor the device within its whole lifecycle and notify the regulating authority on any substantial adverse events within 10 business days upon the discovery of such an event. The manufacturer should also perform corrective and preventive actions necessary to reduce the possible negative impact caused by the device.
- Foreign medical device manufacturers could also provide documents issued by foreign regulating authorities or notified bodies. In the case of Class B, C, and D medical devices it is also required to provide the appropriate international standard.
- Custom-made devices should be provided with the information on the patient that could be identified.
- Labeling requirements are harmonized with the appropriate international standards. The guideline additionally emphasizes that labeling of the device should contain indication of manufacturing or expiry date. For imported medical devices, the importer is the party responsible for compliance with labeling requirements.
The guideline also provides special requirements regarding medical devices supplied in the pack. If the manufacturer combines devices together due to their intended purpose, they are required to submit the appropriate declaration to the regulating authority providing the following:
– The compatibility of the devices has been duly verified,
– The information accompanying the pack is sufficient for the end-user to utilize the device in a safe way,
– All necessary measures of control had been taken,
– If the devices are not compatible, such a pack should pass the assessment necessary for classification.
The Role Of The DGDA
The Directorate General of Drug Administration (DGDA), a division of the Bangladesh Ministry of Health & Family Welfare, is the governmental authority responsible for the regulation of medical device circulation. To exercise its functions, the authority is entitled to perform actions regarding medical devices and all parties involved.
If the device present on the market causes a potential hazard to public health, the authority has a right to take measures necessary to reduce the risk to patient’s health, including restrictions on placing the device on the market to the compulsory withdrawal. The DGDA could take actions if:
– The device fails to comply with the requirements set forth in applicable regulation,
– International standards were applied in the wrong way,
– Imperfections in standards,
– Other reasons resulting in a hazard to the patient’s health.
Depending on the particular situation, other measures such as restrictions, prohibitions or imposing additional requirements could be taken to reduce the risk associated with the device. The authority notifies the manufacturer and/or any other parties involved on the measures taken and the reasons for such measures. The same principle is applicable for any decision taken by state authorities.
According to the regulation, all parties involved in operations with medical devices should maintain the confidentiality of all information they accessed within the course of their activity. At the same time, specific information is explicitly excluded from the confidentiality restrictions, namely:
– Information about the responsible person performing the registration of the device,
– Information that should be provided to users in connections with actions or measures taken by the manufacturer or other party involved,
– Information indicated in the certificate related to the medical device.
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