Medical devices into the new era of GMP into enterprises face high threshold (1)

Recently, the State food and Drug Administration (SFDA) issuance of the medical device manufacturing quality management standards (for trial implementation) "(hereinafter referred to as" specifications "), a total of 13 chapters, applicable to medical device design and development, production, sale and service of the whole process, from 2011 as from 1 January.

At the same time, the SFDA also introduced the medical devices synchronized manufacturing practice check management measures ". This means that our medical device really begin to step into the age of GMP.

"In the context of the new health reform, strengthen the supervision and management of the medical device production, specifications for medical device production quality management system is to protect people with firearms safety, National Council the introduction of the two regulations on medical equipment production quality management is the boost is the spur.

It can be said that this is to promote the medical device industry specific performance gradually mature. "Zhejiang Province Medical Association Hui Pei Quan in acceptance of the pharmaceutical economic newspaper reporter says.

Risk control stressed the "full"

In recent years, foreign medical Giants are fixed on the medical device market in China in the low-end, on domestic medical device company constitutes an enormous pressure.

To this end, has just published the specification gives clear guidance, that is, as a quality management system is an important component, the enterprise should improve production standards in the production process of the implementation of risk management.

Hui Pei Quan said, compared to the previous risk control, the focus of the word "full".

In the past, many enterprises lack of understanding of risk management, in particular SMEs, do tend to be passive, the norms will urge enterprises increase the hardware construction, promote local production of products more secure and effective.

"Highlight the whole risk control is the urgent needs of the industry's progress, especially for aseptic and implanted medical device company plant scale and production capacity, quality management and risk management requirements are adapted.

"Analysts believe, after a year of transition, the whole process control will enter a practical phase, next, implementation will be the focus.

Reporters also informed that the norms defined the manufacturer shall establish and maintain each batch production records.

Production records should meet medical instrument traceability requirements and indicate the number of production volume and libraries and so on, to promote medical device GMP inspection.

"Adhering to the traceability requirements, improve standards is to ensure product quality only.

"Shenzhen Anke high technology co., Ltd. was the Deputy General Manager Wang warfare told reporters. In his view, there is a national brand of prime time.

King will battle explained that because the current foreign medical device only existing products by price means to divide soup China market; plus our grass-roots unit on medical devices operation level will allow foreign medical devices into the low-end market advantage to a fashion.

"In a sense, (the" specifications ") on the domestic enterprises is a kind of protection. ”

Talk about this, Zhejiang Ling Yang medical equipment co., Ltd. General Manager Hu Jun fly quite agree with you.

However, he also expressed some concerns: "the standard" for new product approval requires a little high. ”

Close to international standards

The reporter was informed that the medical device manufacturing enterprises to apply for the first registration and re-registration, should apply for medical device GMP inspection, at the same time the specification is also integrated into the standard international ISO13485.

Hui Pei Quan considers the source build related production enterprise standards and restraint mechanisms, to promote medical device manufacturing enterprise of overall quality and medical device regulatory level to breathe.

"It can be said to enhance medical device manufacturing management standards with international standards, is a medical device company based on the local community, the only way to positively engage the world. ”