Drugdu.com expert's response:

The reasons for requiring CE certification in domestic medical device tenders can be elaborated from multiple perspectives:

Ⅰ. International Recognition and Market Access of CE Certification

International Recognition: CE certification is a prerequisite for market access in Europe. Medical devices with CE certification must comply with European standards such as EN60601 and EN45545. This signifies that CE certification not only enjoys a high level of recognition in the European market but is also globally recognized as an important indicator of product quality and safety.

Market Access: For medical device manufacturers aiming to enter the European market, CE certification is indispensable. Without the CE mark, it is illegal to sell or distribute medical devices within the European Economic Area. Therefore, requiring CE certification for domestic medical devices in tenders helps enhance their competitiveness in international markets.

Ⅱ. Enhancing Product Quality and Safety

Quality Improvement: To obtain CE certification, domestic medical device manufacturers must continuously improve product quality and safety to meet European standards. This pursuit of quality contributes to elevating the overall standards of domestic medical devices.

Safety Assurance: CE certification ensures that medical devices meet essential safety, health, and environmental protection requirements. For hospitals and other procurement parties, medical devices with CE certification offer higher guarantees in terms of quality and safety, thereby reducing procurement risks.

III. Strengthening Brand Competitiveness and Market Image

Brand Competitiveness: Requiring CE certification in tenders enables domestic medical device manufacturers to become more competitive. Products with CE certification are more easily recognized in European and American markets, leading to increased sales and market share.

Market Image: CE certification also provides domestic medical device manufacturers with a better market image and enhances brand awareness. This helps enterprises stand out in fierce market competition and attract the attention of more potential customers.

Ⅳ. Meeting the Procurement Needs of Tendering Parties

Procurement Standards: With the rapid development of medical technology and the continuous improvement of people's demands for medical device performance and safety, tendering parties have increasingly stringent requirements for medical devices. As an internationally recognized quality and safety mark, CE certification has become an essential consideration for tendering parties in the procurement process.

Risk Reduction: For tendering parties, selecting medical devices with CE certification reduces procurement risks. These products have undergone rigorous review and testing in terms of quality and safety, ensuring that they can achieve the desired effects during use.

In summary, the reasons for requiring CE certification in domestic medical device tenders mainly include international recognition and market access, enhancing product quality and safety, strengthening brand competitiveness and market image, and meeting the procurement needs of tendering parties. These factors collectively contribute to the increasing significance of CE certification in domestic medical device tenders.