Drugdu.com expert's response:

The main reasons for medical device industry to strengthen compliance management under the normalization of centralized procurement can be summarized as follows:

I. Policy Drives and Strengthened Regulation

1.Normalization of Centralized Procurement Policy: The normalization of centralized procurement in the pharmaceutical industry refers to the long-term, stable, and institutionalized practice of governments or relevant agencies to conduct bulk procurement of medical products and services such as drugs and medical devices. This model aims to reduce procurement costs, improve procurement efficiency, ensure the quality and supply of drugs and medical devices, thereby meeting the basic medical needs of the people. Under the centralized procurement policy, medical device companies need to pay more attention to compliance management.

2.Strengthened Regulatory Efforts: With the promotion of numerous national policies such as medical anti-corruption, centralized procurement, and joint procurement, medical reform has been fully integrated into the overall process of deepening reforms, and regulatory efforts have gradually intensified. Regulators are increasingly emphasizing digital management and compliance of medical device companies to ensure product quality and safety.

II. Reducing Compliance Risks and Ensuring Steady Development

1.Avoiding Irregular Operations: Companies must comply with relevant laws, regulations, and policy requirements, standardize their business conduct, and avoid compliance risks arising from irregular operations. For example, in marketing and promotion, companies should avoid irregularities such as false academic conferences and illegal sponsorships to prevent penalties and damage to corporate reputation.

2.Ensuring Steady Development: By strengthening compliance management, companies can ensure steady development in a complex and ever-changing market environment. Compliant operations not only help reduce legal risks but also enhance corporate credibility and market competitiveness, laying a solid foundation for long-term development.

III. Enhancing Corporate Management Level

1.Digital Transformation: Digital transformation and business compliance are key priorities for future medical device companies. Through digital transformation, companies can establish a more standardized and efficient management system, achieve comprehensive data recording and tracing, and provide strong support for compliance management.

2.Process Optimization: Compliance management requires companies to continuously optimize internal processes to ensure that all links comply with regulatory requirements. This not only improves operational efficiency but also reduces operational costs, enhancing the company's overall competitiveness.

IV. Ensuring Patient Safety in Device Use

1.Product Quality and Safety: Medical devices are closely related to human life and health, making it crucial to ensure their quality and safety. By strengthening compliance management, companies can more strictly control product quality, ensuring that patients use safe and effective medical devices.

2.Protecting Patient Rights: Compliance management also involves safeguarding patient rights. Companies must ensure that during production, sales, and use of products, they fully respect patients' right to know and choose, protecting patients' legitimate rights and interests from infringement.

In summary, strengthening compliance management in the medical device industry under the normalization of centralized procurement is a shared requirement driven by policies, reducing compliance risks, enhancing corporate management levels, and ensuring patient safety in device use. Companies need to actively respond to policy calls, strengthen internal management, ensure compliant operations, and contribute to the healthy development of the industry.