The certification audit standards and requirements of the Bangladesh Drug Administration (DGDA) for medical devices are one of the key factors to ensure that medical device products are safe and effective in the Bangladesh market. The following are the main audit standards and requirements for Bangladesh DGDA certification of medical devices:
Comply with international standards
Medical device products must comply with internationally recognized technical standards and specifications, such as those issued by international standards organizations such as ISO, IEC, ASTM, etc.
DGDA will require products to comply with the corresponding international standards and specifications according to the use and characteristics of the products.
Quality management system
The applicant enterprise must establish and implement an effective quality management system to ensure that the production process and quality control of the products meet the specified standards and requirements.
The quality management system should cover the whole process from product design, procurement of raw materials, manufacturing, quality inspection to after-sales service.
Product technical requirements
Medical device products must have the required technical performance and functionality to meet their intended clinical or medical use.
The technical requirements of the product should match the product's design purpose, target user group and application environment.
Biocompatibility and safety
Medical device products must be tested for biocompatibility to ensure that they are compatible with human tissues and physiology and do not cause adverse effects on the human body.
Product materials should comply with relevant biocompatibility standards and requirements to ensure the safety and reliability of the product.
Quality control and inspection
The applicant enterprise must establish a sound quality control and inspection system to conduct comprehensive quality inspection and testing of the products.
Including raw material inspection, production process control, finished product inspection, etc., to ensure the quality stability and reliability of products.
Technical documentation and proof of registration
Applicants must provide complete technical documents, including product design documents, technical specifications, production process flow charts, test reports, etc.
If the product has obtained a certificate of registration or license in the country of origin or production, the corresponding registration certificate document is also required.
On-site inspections and audits
DGDA may arrange on-site inspections and audits to verify that the Applicant Company's manufacturing practices and quality management system comply with the specified standards and requirements.
The inspection content includes production facilities, equipment management, personnel training, quality records, etc.
Regulatory and Legal Compliance
Applicants must comply with Bangladesh's relevant medical device regulations and legal requirements to ensure that the production, sale and use of products comply with laws and regulations.
The labeling, instructions and packaging of the product shall comply with the requirements of Bangladesh's regulations and standards.
To sum up, the audit standards and requirements for medical device Bangladesh DGDA certification cover product quality, technical performance, biocompatibility, quality management system, legal compliance and other aspects. Applicants must ensure that their products meet the relevant requirements and provide sufficient application materials and supporting documents to ensure that they successfully pass the certification audit and obtain the certification certificate.