My firm has been working in the Chinese medical device market for more than 25 years. We help foreign device companies register, source and sell devices there. About 10 years ago, we were doing an audit for a U.S. device company that was sourcing from a Chinese factory. At that time, the quality of Chinese products was generally very poor, and there were many issues regarding quality assurance (QA).
To give an idea of some of the quality problems that exist in Chinese manufacturing facilities, I have included excerpts from the email correspondence between our auditor and the Chinese factory.
The initial email from our auditor addressed the severe QA issues at the Chinese factory:
“The factory manager has been working with the Chinese factory’s process engineers and technical staff to come up with a batch record that contains clear and sufficient operational instruction and detailed records to be used at the time of performance. This is the highest priority. Without executable batch record, no validation can begin. The seriousness of the compliance problem at the Chinese factory cannot be overstated—no executable written procedures, including the batch instruction, or records existed at the plant. They were constantly changing process parameters without records, leading to the loss of important historical data and valuable institutional memory on manufacturing experience. We will try our best to bring them up to speed.”
The second email from our auditor pointed out problems with the management at the factory that contributed to their compliance issues:
“I had a face-to-face discussion with the Chinese factory manager to find solutions for significant problems and to update him on the tasks we finished. After this talk, I can feel he is not 100% committed to address the identified issues in the best way; rather, he looks for second-best solutions or even excuses not to do this. He believes we are doing too many things of which the requirement is not appropriate for them. He even says the overseas purchaser may not establish a certain standard operating procedure or qualify an equipment supplier as the Chinese factory is required.”
The reply from the Chinese factory:
“I totally agree with your points. I will get the management to become more involved with this project. The continuous training is very important to us. I will make sure this will be enforced. The Chinese factory has also invested quite a lot in this project. We are definitely losing money due to the accommodation of the project process, QA requirement, and the resources put in, which affects our ability to run other projects. We want to move the project forward as much as you do.”
Those were the days! In the past so many Chinese device factories needed a great deal of help. Today, many Chinese factories have initiated a better QA system. Many Chinese factories have adopted ISO 13485, and some have even gained FDA approval. More work still needs to be done, but QA in China is improving steadily.
Recently, the China Food and Drug Administration (CFDA) has taken a much more aggressive stance toward improving quality at local device companies via new regulations. The major regulations are outlined in Table 1.
| December 2014 |
The CFDA released two pieces of legislation that further developed quality management system standards for the manufacturing and distribution of medical devices in China. The first is China’s medical device Good Supply Practices (GSP) regulations, which took effect immediately.The second is a revised medical device Good Manufacturing Practices (GMP) regulation, which went into effect on March 1, 2015. This will include the CFDA doing on-site inspections for sterile devices, implantable devices, and IVDs. The revised GMP regulations will require medical device manufacturers to implement a risk management system throughout the device development, production and post-market process. |
| July 2015 | The Chinese Food and Drug Administration (CFDA) announced that it will begin to conduct regular surprise inspection of medical device and pharmaceutical manufacturers starting on September 1, 2015.
The new inspection policy is intended to bolster the quality of medical devices and pharmaceuticals manufactured in China by enabling the CFDA to catch manufacturers before they can destroy any incriminating evidence. |
| October 2015 | The China Food and Drug Administration (CFDA) issued more comprehensive guidelines for manufacturing three types of medical devices: sterile and implantable devices, and in-vitro diagnosis reagents.
These guidelines aim to improve the administration and quality management of medical devices in China in order to ensure their safety and efficacy. |
Thus, the quality of medical devices in China is improving, but how rigorous the Chinese CFDA enforces such new regulations will be crucial going forward.
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