Recently, HTDK successfully obtained dual certifications of GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) from the international certification body SGS, in accordance with the standards of the World Health Organization (WHO). This significant milestone establishes HTDK as a benchmark for quality standards and compliance in the medical device industry.

GMP and GDP are critical standards in the global pharmaceutical industry, designed to ensure that the production and distribution processes of pharmaceutical products meet high standards of quality and safety. Obtaining these certifications means that HTDK adheres to high standards and compliance in the fields of simple processing, production, and distribution of pharmaceutical products, ensuring traceability of product quality and safety.

By achieving GMP certification, HTDK has demonstrated its commitment to best practices in the simple packaging and production of pharmaceutical products. This certification acknowledges that the company’s production facilities and operational processes comply with international standards, including excellent hygiene conditions, an effective quality management system, and comprehensive training and qualification of staff. This will help ensure that our products consistently meet high-quality standards and satisfy customer expectations.

The GDP certification further consolidates HTDK’s excellence in product distribution. This certification ensures compliance and transparency in the supply chain and distribution process. HTDK will implement a series of measures to guarantee the quality and safety of products during storage, transportation, and distribution.

Aileen Zhu, Head of QA at HTDK, stated, “We are extremely proud of this achievement and see this certification as a recognition of our long-term commitment to product quality and compliance. This certification will further strengthen HTDK’s reputation in the industry and enhance trust with our partners and customers. In the future, HTDK will continue to commit to continuous improvement and adherence to best practices to ensure that our products and services remain at the forefront of the industry. We will continue to work closely with regulatory authorities, partners, and customers to ensure ongoing quality and compliance.”

In addition, HTDK has obtained various qualifications and recognitions in different areas of quality control and information security, including Class III and Class II medical device business licenses, third-party medical device logistics service qualifications, hazardous chemicals business licenses, and ISO 13485:2016 and ISO 9001:2015 international certifications for medical device import, storage, logistics, relabeling, repackaging, and distribution. The company also holds AEO advanced customs certification and ISO 20000 and ISO 27001 information security management system certifications. HTDK places a high value on quality and safety, which is crucial for the continuous development and maintenance of future markets.

The company’s strict adherence to industry regulations and standards, as evidenced by the successful acquisition of GMP/GDP certification, demonstrates its commitment and efforts in ensuring compliance and high quality throughout the entire production and distribution process. This will further enhance the company’s competitiveness and market share, providing more reliable and trustworthy products and services to partners and customers.

In the future, HTDK will continue to strengthen its internal quality management system and continuously refine production and distribution processes to meet evolving regulatory requirements and market demands. The company will maintain close collaboration with regulatory bodies to ensure its operations consistently meet the highest standards and requirements.

Obtaining GMP/GDP certification marks a new beginning for HTDK. The company will strive for higher standards and broader goals, continually innovating to enhance the accessibility of innovative medical devices from China to the global market.