Medical Devices Enters the GMP Era

Business Club News, January 7 Recently, the State Food and Drug Administration (SFDA) issued a total of 13 chapters on the “Medical Device Manufacturing Quality Management Specification (Trial)” (hereinafter referred to as “the Code”), which is applicable to the design and development of medical devices. The whole process of production, sales and service will be implemented on January 1, 2011. At the same time, the SFDA has also issued the "Measures for the Administration of Inspection of Medical Device Manufacturing Quality Management Specifications". This means that China's medical devices really begin to enter the GMP era.

“In the context of the new healthcare reform, strengthening the supervision and management of medical device production and standardizing the medical device production quality management system are fundamental to safeguarding the safety of the people’s machinery. The two regulations issued by the State Bureau are an inspiration to China’s medical device production quality management. It is also a spur. It can be said that this is a concrete manifestation of the gradual maturity of China's medical device industry.” Xu Peifu, president of the Zhejiang Medical Device Industry Association, said in an interview with a reporter from the “pharmaceutical economic newspaper”.

Risk Control emphasizes "whole process"

In recent years, foreign-funded medical device giants have also stared at China's low-end medical device market, which poses a great pressure on domestic medical device companies. To this end, the newly issued "Code" gives clear guidance, that is, as an important part of the quality management system, companies should raise production standards and implement risk management throughout the production process.

Xu Peixi said that compared to the previous risk control, this time highlighted the "full process" word. In the past, many companies lacked awareness of risk management, especially small and medium-sized enterprises. They often passively set standards. The "Code" will urge enterprises to increase their hardware and software construction, and to promote domestic products that are more secure and effective.

“Outstanding full-process risk control is an urgent need for industrial progress, especially for the scale and production capacity of aseptic and implantable medical device companies, whether quality management and risk management requirements are appropriate, etc.” Analysts believe that after one In the year of transition, the entire process of control will enter the actual operation stage. Next, implementation issues will become the focus of attention.

The reporter also learned that the "Code" clarifies that production companies should establish and maintain the production records of each batch of products. Production records should meet the traceability requirements of medical devices, and indicate the number of production and the number of warehousing, etc., in order to promote the GMP inspection of medical devices.

"Adhering to traceability requirements, raising standards is the only way to protect product quality." Wang Bizhan, deputy general manager of Shenzhen Anke High-tech Co., Ltd., told reporters. He believes that at present it is a prime time to build a national brand.

Wang Bizhan explained that because the current foreign-funded medical devices only use the price cuts to subdivide the Chinese market for existing products, coupled with the limited level of medical equipment operation of the grass-roots units in China, the advantage of foreign-funded medical devices in the middle-to-low-end market will be a fashion trend. Difficult to reflect. "In a sense, (the "Code" is a kind of protection for domestic enterprises."

Talking about this, Hu Junfei, general manager of Zhejiang Lingyang Medical Devices Co., Ltd., agrees. However, he also expressed some concerns: "The "specification" requirements for new product approval requirements are a bit high."

Close to international standards

The reporter was informed that when a medical device manufacturing company applies for the first registration and re-registration of a product, it should apply for a GMP inspection of the medical device. At the same time, the "Guidelines" also incorporate international ISO13485 standards.

Xu Peixi believes that the establishment of the normative standards and restraint mechanisms of relevant manufacturers from the source will greatly benefit the overall improvement of medical device manufacturers' overall quality and the level of medical device supervision and management. “It can be said that improving the standards for the management of medical device production is in line with international standards, and it is the only way for Chinese medical device companies to base themselves on the local market and actively go global.”

In this regard, Li Dongyi, director of technical regulations of Mindray Biomedical Electronics Co., Ltd., also believes that some provisions of the “Guidelines” draw on the internationally accepted ISO13485 certification standards, and actively move closer to the QSR standards, bringing China’s medical device quality management system to the form of laws and regulations. Established is an initial experience that tries to be in line with international standards.

However, some people think that due to the improvement of entry barriers and the content of some articles is too principled and instructive, the operability is not strong, and software management is not specific enough, and it is difficult to form a synergy.

Wang Bizhan said that companies that have passed the ISO13485 certification can only exchange certificates according to their requirements, and new companies entering the market will face a higher threshold of entry. Whether it is timely to revise the company's own process management and complete the process management plan from April to May 2010 is still a big test for SMEs.

"Of course, industrial upgrading, survival of the fittest is inevitable. For example, the "Code" clearly stipulates that production companies should establish control procedures for product identification and form a document, clearly in the entire process of product realization, product identification with appropriate methods. In order to identify such contents, it is exactly what many companies are currently neglecting.” Hu Junfei believes that conforming to the general trend of the market and trying to be in line with international standards is worthy of recognition, but in practice the requirements for upgrading software and hardware should be gradual, especially for new products. Policy protection.

The reporter learned from relevant parties that in order to better implement the "Code" and regulate the production quality management system for aseptic and implantable medical devices and their supervision and inspection work, the State has also issued the "Medical Device Manufacturing Quality Management Specification aseptic Medical Device Implementation Regulations (Trial) and Implementation Regulations for Implantable Medical Devices for Medical Device Manufacturing Quality Management (Trial).

Xu Peixi said that weaving more and more stringent regulatory networks is a necessary guarantee and foundation for gradually integrating with the world and creating a national brand.