Summary of Key Points
Japanese medical device company, Hyolite Surgical, has had its import and use of artificial bone products suspended by the national drug regulatory authority due to deficiencies in its quality management system (lack of verification in critical production processes and inadequate product inspection). The company was also disqualified from participating in national procurement auctions and banned from applying for participation for one and a half years. This incident not only shatters the myth that "Made in Japan" equals high quality but also exposes the issue of some imported brands relying on the aura of "original imports" while neglecting quality control. It demonstrates China's determination to strengthen the regulation of imported medical devices through cross-border inspections—importation does not guarantee reliability; quality is the true determinant.
I. Hyolite Surgical’s Failure: A 40-Year-Old Company Struck by Basic Quality Issues
Hyolite Surgical, a subsidiary of the Hyolite Group in Japan, has been in the medical device industry for over 40 years and was the first company in the country to produce artificial bones. In 2023, its synthetic bone product won a bid in the fourth batch of high-value consumables procurement auctions at an extremely low price of 169 yuan/cm³, earning praise for the active participation of a multinational company in China’s procurement process.
However, the good times were short-lived. The national drug regulatory authority discovered issues with the company’s production processes, such as the lack of verification of stability in key material processing steps and inadequate product inspection before shipment, posing safety risks to patients. As a result, Hyolite Surgical’s import, operation, and use of its products were suspended, and it was barred from participating in future procurement auctions for the next 18 months.
The affected β-tricalcium phosphate artificial bone is a commonly used material in orthopedics for filling fracture gaps and promoting new bone growth; poor quality could lead to serious health risks, although the specific consequences have not yet been disclosed by authorities.
II. The Myth of “Made in Japan” Is Cracking Apart—It’s Not an Accident
The perception that “Made in Japan” equals craftsmanship is widespread, but recent years have seen a series of quality scandals involving Japanese companies:
- Kobe Steel: Decades of data fraud affected hundreds of companies worldwide;
- Kobayashi Chemical: Over 500 drug production processes were found to be defective, leading to business suspension;
- Asahi Brake Systems: Falsification of 110,000 quality inspection records.
Hyolite Surgical is just another example of a long-established company failing due to basic quality issues, indicating that the so-called “craftsmanship” is no longer credible, and lax quality management has become a common problem.
III. Why Do Imported Brands Frequently Fail?
Problems with imported medical devices are not limited to Japanese companies; Korean, German, and Italian brands have also encountered issues:
- Korean company Hansoh Bioscience’s bone repair materials, Italian Sammo’s artificial joints, and German Carl Zeiss’ intraocular lenses have all had imports suspended due to quality concerns;
- Korean company Kolintai even refused a cross-border inspection by Chinese authorities, resulting in a complete ban.
There are two main reasons for this:
1. Cost Reduction for Bidding in Procurement Auctions: Procurement auctions require companies to bid at low prices, and some imported brands may cut corners on quality to win bids (for example, Hyolite Surgical’s low bid may have come at the expense of quality).
2. Lack of Respect for Chinese Regulations: In the past, imported brands relied on the “original import” label to gain trust, assuming that Chinese authorities could not oversee foreign factories; however, now Chinese regulators can conduct inspections directly abroad.
IV. Cross-Border Inspections: Making Imported Products Unhidable
How do Chinese regulators identify issues with foreign companies? Through cross-border inspections—sudden unannounced visits to production facilities to check raw materials, production processes, and inspection records.
In 2018, the National Medical Products Administration issued regulations specifying that any product intended for sale in China can be inspected regardless of the country of origin. In recent years, Chinese inspectors have visited factories in Japan, Germany, Italy, and other countries, uncovering numerous issues. For instance, Carl Storz, a globally renowned endoscope company, had its high-frequency surgical equipment imports suspended due to shortcomings in software version control and adverse event analysis. Cross-border inspections make it impossible for imported brands to rely on past successes.
V. The Lesson: The Import Aura Is Losing Its Power—Quality Is the Real Factor
Previously, patients and hospitals assumed that “imported” products were of higher quality, but these cases show that:
- Importation Does Not Guarantee Reliability: Even established brands with a long history and good reputations cannot escape current quality issues.
- Companies Must Comply with Regulations: Whether domestic or foreign, companies must maintain strict quality control to survive in the Chinese market.
- Increasingly Stringent Regulation: China’s quality standards for imported medical devices are as strict as those for domestic products; there is no leniency based on origin.
For consumers, choosing medical supplies should no longer be based solely on whether they are imported. For companies, focusing on quality is essential to gain market success.
In summary, the Hyolite Surgical incident is not an isolated case; it reflects the fading prestige of imported brands and the strengthening of Chinese regulatory measures. Quality is the ultimate determinant for a company’s success, regardless of its country of origin. All must adhere to Chinese regulations.