Ameing for Asia

Quality Matters: Do It Right the First Time

By Ames Gross
July 18, 2016


• Categories: 05-Quality/Regulatory, Ameing for Asia, Market Access

As medtech companies move into the Asian markets, they will find that the Chinese medical device registration process can be very difficult. Today, it is often easier to get products registered in Japan than in China. Although Japan has a very demanding and highly detailed registration process, it is generally more transparent than the process in China.

Obtaining registration approval in Japan requires excellent on-the-ground regulatory affairs (RA) personnel. Over the last 25 years, I have seen many companies hire the wrong RA employees for their Japan office or the wrong regulatory consulting company. There is a severe shortage of efficient and competent Japanese RA executives.

For example, a few weeks ago a U.S. medtech company contacted me about its slow registration in Japan. I was surprised to learn this because they were working with a Class II product, which should normally take about 12 to 15 months to register. However, this company had been trying to register its product in Japan for more than three years.

After discussing the situation in more detail with this medtech company, I asked for the resumes of the RA employees they had on their Japan team. Upon reviewing these resumes, I saw that I was familiar with several of the medtech companies where two of the RA employers had previously worked. In fact, I had friends still working at those companies. When I called my Japanese RA friends in these companies and asked about the two specific people working at the foreign medtech company’s Japan office, I learned that neither one of these Japanese RA employees had ever really been involved with putting dossiers together or responding to the Japanese regulatory authority’s product registration questions. While both of these RA executives spoke English fluently, the problem lied in the fact that they lacked sufficient RA experience.

During this time, we also reviewed the initial Japanese dossier that was submitted three years ago and identified several problems. After looking further into the questions and the answers provided to us by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) over the last few years, we were sure that there were other underlying problems as well. We are now working with this U.S. client to salvage the work that has been done over the last three years and get their product approved.

In another example a number of years ago, I was working with a small startup device company that wanted to enter the Japanese market. The company had sales of about $20 million, but it was still looking for capital to grow its business. A large Japanese trading company decided to invest $5 million into this startup device company in exchange for the Japanese distribution rights. This large Japanese trading company had a medical device distributor subsidiary in Japan and wanted its own distributor to register the foreign company’s devices in the country.

Unfortunately, the Japanese RA staff at this distributor only had experience with selling basic devices in Japan, where registration is fairly straightforward. In this case with the foreign start-up company, the product was a higher class device that required local clinical trials to be conducted in Japan in order to obtain product approval. The Japanese distributor did not have any experience with clinical trials, so when they completed the local trials and submitted the dossier to the PMDA, they were told that the clinical trials had not met Japanese Good Clinical Trial Practices (JGCP). Thus, the trials would need to be redone, thereby increasing the time until approval as well as the overall cost of registration. Because of the clinical trial problems, the Japanese PMDA was reluctant to register the product even after new proper clinical data was submitted. It took another five years to get the device registered in Japan, and the opportunity cost of lost sales was quite significant. Moral of the story: Quality matters in Japan, and things need to be done correctly the first time.

Obviously, there are some very good Japanese regulatory people that work at Western companies’ Japan offices as well. For example, several years ago a U.S. medtech company called us to complain about the slow registration process in Japan. Evidently top management was very displeased that their products had not been registered yet, and so we were hired to conduct an audit of their Japan office.  After meeting their team in Japan, reviewing the dossiers they submitted, and so on, we concluded that these RA personnel and their work were actually excellent, and the lengthy registration process was due to factors outside of their control. We advised the Western company to do all they could to retain their excellent RA people for fear that they could be easily poached.

There are excellent regulatory professionals in Japan, but the bottom line is that you need to conduct a lot of due diligence before hiring your Japanese RA personnel. Half of the companies we have worked with have had significant product registration delays, and they all had the common underlying problem of having an unqualified RA team in Japan. If you put in the time and effort to hire the right Japanese regulatory team in the beginning, it could ensure the success of your product registration and save you a great deal of time and money later.