For medical device makers the device market in Japan is a literal gold mine.
Healthcare reporter Vita Reed says it best when she states that "Japan's aging population and tremendous national wealth should make the country a natural for medical device makers."1
Additional Attractions of the Japanese Med Device Market
It isn't only the need for devices and the ready funding that attracts U.S. device makers to Japan. Japan's medical device expertise also acts as an added enticement. Device makers in Japan have a specialized knowledge that U.S. device makers could learn from and vice versa.
Generalized market statistics also seem to infer that a med device relationship should be contracted between the U.S. and Japan. The U.S. for instance currently has the largest medical device market and Japan has the second. Business between the two markets seems natural---doesn't it?
The U.S. Agrees. Does Japan?
Most U.S. device makers and regulators would agree that parallel requirements make sense but do Japanese device regulators concur?
It seems that (from a U.S. perspective at least) Japanese regulators do agree and at the same time don't, which for impatient U.S. device makers is a situation that creates sentiments that Reed succinctly summarizes as: "Selling there [in Japan] can be an exercise in frustration."
Why the frustration?
Why all this frustration in creating harmony between the two medical device regulatory systems? Can't the two med device markets just get along?
Well, in short, there are several issues which make harmonization a complex endeavor:
Issue #1: Past Harmonization Efforts
One reason for the "harmonization frustration" is simply the small amount of progress that has been made during many years of harmonization effort.
For example, harmonization efforts between the two countries began years ago and were later officially and governmentally organized in December of 2003 as the U.S.-Japan HBD initiative or the Harmonization by Doing initiative. The program was launched as a pilot endeavor in December of 2003 and was officially established by the CDRH (Center for Devices and Radiological Health and the PFSB (Pharmaceutical and Food Safety Bureau) which is an entity within Japan's Ministry of Health, Labor and Welfare (MHLW). A Japanese reviewing agency, the PMDA (Pharmaceuticals and Medical Devices Agency) was also involved.
The initial goal of the project according to these agencies included the elimination of regulatory barriers so that medical devices could be approved in a timely manner. Additional goals, established in 20052, also included the following:
These combined goals have led to some traceable steps forward, although they are just baby steps in the grand scheme of parallel regulations.
Other related progress has also occurred however. For example, in addition to the HBD project there are, according to Ames Gross, president of Pacific Bridge Medical (consultants on China medical device regulations), "plans to increase the number of reviewers by 30 percent in the next year or two."
An industry expert, quoted by FDA News, describes the issue well when he states that "while the path to registering and marketing a medical device in Japan is improving, the process is still slow and burdensome."
Issue #2: Strict and Demanding Regulations
Another roadblock for the realization of HBD harmonization ideals are the regulatory laws that currently exist for foreign device makers entering the Japanese market. Gross, for instance, states that "Foreign firms are required to provide so much data under Japan's Pharmaceutical and Medical Devices Agency (PMDA) regulations that small firms may wonder if it's worth it."
These seemingly unbendable laws have not always stood as ominous sentinels to U.S. device makers. In fact, an online article3 published by the MedicalDeviceResourceGroup.com states that "Prior to 2000, medical device applications and approvals were generally easy to understand, prepare, and obtain. Broad categories of devices could be applied for and obtained, even if data only existed for a small portion of these devices. It was not uncommon to obtain approvals on certain device models long before they were designed."
However, this situation, on its way to even better results with the help of the HBD initiative, found itself regressing when changes were made to the PAL (Pharmaceutical Affairs Law) of Japan. These changes were actualized in 2004 and implemented again in April 2005. The changes resulted in a regulatory scene where "submission and GMPi requirements (became) more clear, but also more difficult to meet."4
The same Medical Device Resource Group article describes some of the implemented changes:
"Also implemented as part of the 2005 PAL revision implementation is the creation of an entity in Japan entitled Marketing Authorization Holder (MAH). In the past, a US manufacturer could either register their products with MHLW directly (Foreign Manufacturer Approval) and appoint a local agent (In-Country Caretaker), or allow an agent/distributor in Japan to register the product in the name of that agent/distributor (Import Approval). With the implementation of the 2005 PAL revisions, the ability to utilize these two systems has changed dramatically, eliminating the roles of In-Country Caretaker and abolishing the Import Approval scheme.
Under the 2005 PAL revisions, a MAH is responsible for all aspects of product quality, registration, and post-market surveillance. The MAH is responsible for obtaining registrations, ensuring the quality systems of the manufacturing facilities, developing release criteria in Japan for each imported product, retention of manufacturing, QC, distribution records, and complaint records, and compliance with Japan vigilance requirements.
Various MHLW offices were also combined in an effort to reduce costs and increase efficiency. Also the submission and GMPi requirements have become more clear, but also more difficult to meet. Lastly, it is documented that MHLW will continue to accept ISO 10993 data, but there still is unique extraction conditions that require additional biocompatibility testing for Japan in the areas of cytotoxicity, sensitization, and hemocompatibility."
The vast amounts of data transfer requirements and the fact that Japanese regulators will (at times) ignore clinical studies that have already been performed in the U.S. is an obvious frustration to U.S. device makers who are comfortable with shorter product cycles.
Issue #3: Cultural Implications
Another obvious problem standing between parallel U.S. and Japanese regulations are the cultural differences between the device makers themselves. Gross states that "Fifty percent of problems with large manufacturers is due to lack of trust." Gross also stresses, according to FDA News, "the importance of doing face-to-face business in Japan and understanding cultural nuances." In fact, Gross states specifically that "Japanese companies make decisions by consensus; decisions are rarely made by a single individual."
What will it take?
When all is said and done, it seems that U.S. device makers need to sit down and really decide whether doing business in Japan is worth the time, the money and the learning that such an endeavor will require. The sacrifice can be great. According to the same FDA news article for instance, Gross advises "manufacturers to take advantage of the new consultative sessions added by the PMDA to speed product reviews. Fees range from $200 to more than $12,000. But the consultations are worth the expense as they give companies the opportunity to build trust with Japanese officials."
Medical device expert Matt Lowe adds the following:
"Entering the Japanese market is a huge endeavor and should not be taken lightly. While regulations often follow ISO and FDA standards, review times and special requirements result in a much longer regulatory approval process. Having a Japanese partner and following JIS guidelines whenever possible are highly recommended for anyone looking to gain regulatory approval in less than 18 months. Be prepared to provide piles of documentation and wait long periods of time between communications."
In short, it seems that U.S. device makers can take the following steps to try and bridge the gap between the U.S. and Japanese medical device markets:
Though the "coming together" process for U.S. and Japanese medical device makers may at times be tedious, U.S. medical device makers are still on their toes peeking around the med device corner for possible opportunities in the very promising Japanese medical device market.
Marci Crane is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).
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