Well (deep subject, the doctor knows), I know many of the readers were wondering about Dr. D’s next series. The doctor really wanted to make this next series an enjoyable surprise. That being said, surprise, surprise, surprise (thank you Gomer Pyle USMC); the next series of Dr. D’s articles will be focused on complying with MHLW Ministerial Ordinance Number 169. For those of you not familiar with the medical device opportunities in Japan, the Japanese device market is second only to the United States. In fact, the Japanese device market is estimated to be in excess of $25B (US) a year. That my dear readers, is a whole bunch of yen. Additionally, 35% of the devices used in the Japanese market are imported. Let me see, 35% of $25B (US) equates to $8.75B (US). Once again my dear readers, that is a whole bunch of yen. With that much potential revenue at stake, I hope the readers take a copious amount of notes as Dr. D provides some insight and guidance into complying with the regulations imposed by the Ministry of Health, Labor, and Welfare (MHLW). In this initial article, the doctor will provide some background on the meaning/purpose of MHLW, the Japanese Pharmaceutical Affairs Law (JPAL), Pharmaceuticals and Medical Devices Agency (PMDA), a 50,000’ overview of device classifications, Japanese Industrial Standard (JIS), and Ministerial Ordinance (MO) 169. As you can already see, the doctor is throwing several new acronyms (MHLW, JPAL, PMDA, JIS, and MO) at the readers as the subject matter changes from the European Union (EU) and their Directives to the land of the rising sun. For those of you familiar with the doctor’s fine prose, I promise to be as irreverent as ever for this series. However, Dr. D will not throw himself onto the proverbial sword, in recognition of the ancient tradition of “hara-kiri” (look-it-up).
Japan’s Ministry of Health, Labor, and Welfare is a Japanese cabinet-level ministry charged with providing regulatory oversight for food, food additives, drugs, and medical devices. Since September of 2011, Yoko Komiyama (not to be confused with Yoko Ono) has been tasked with MHLW oversight as the minister. Similar to the FDA, the ministry is an extremely large and complex organization. In fact, Dr. D believes it is considerably more complex than the agency.
The Japanese Pharmaceutical Affairs Law is the law that regulates drugs and medical devices for entry into the Japanese market. The law covers the manufacturing, sale, and importation of drugs and devices into Japan. The original piece of legislation entered into law in 1960. Since inception, there have been multiple amendments. In 2002, an amendment to JPAL resulted in an improved alignment between Japan, Europe, and the United States in regards to standardization of regulatory requirements. Similar to Europe and the United States, device classification for Japan is now premised on risk.
The Pharmaceuticals and Medical Devices Agency is tasked with reviewing applications for pharmaceuticals and medical devices. Taking the concept of employing risk-based policies to assess drug and device applications to a new level, PMDA employs science-based judgment when assessing the quality, safety and efficacy of medical devices. Remember, through PMDA all good medical devices must pass. Additionally, PMDA retains the right to perform audits on manufacturers of Class II, Class III, and Class IV devices.
Japan employs a device classification system that contains four device classes. It should be noted that Japan does not recognize European CE marked product or FDA cleared devices as relevant during the application review and approval process. That being said, the classes associated with Japan are:
• Class I Devices (Todokede) – (General) need to file a pre-market submission (no assessment by PMDA required);
• Class II Devices (Ninsho) – (Specified Controlled & Controlled) need to submit pre-market certification application to a Registered Certified Body (RCB) – i.e., SGS, TUV-R, TUV-SUD, DEKRA, etc. (note some Class II devices require pre-market approval);
• Class III Devices(Shonin) – (Highly Controlled) need to submit the pre-market approval application directly to PMDA; and
• Class IV Devices (Shonin) – (Highly Controlled) need to submit the pre-market approval applications directly to PMDA.
Japanese Industrial Standards are managed by the Japanese Industrial Standards Committee (makes sense to Dr. D). The law enacting and mandating the use of JIS was the Industrial Standardization Law (1949). A significant revision to the law occurred in 2004. The actual JIS Mark of Certification has also changed, with the new mark required on all products since October of 2008. The reason Dr. D has included a brief summary of JIS is because certain JIS may be required when testing devices slated for entry into the Japanese market.
Ministerial Ordinance 169
MO 169 is the Japanese Ministerial Ordinance on Standards for manufacturing Control and Quality Control for Medical devices and In-Vitro Diagnostic Reagents. MO 169 is comprised of five (5) Chapters, six (6) Sections, and eighty (80) Articles. In general, MO 169 is the foundation for Quality Management System (QMS) requirements required for device manufacturers wishing to enter product into Japan. Unlike EN ISO 13485:2003, MO 169 compliance is categorized as an accreditation for foreign manufacturers and licensure requirement for domestic Japanese manufacturers.
The biggest takeaway from this week’s guidance is that entering medical devices into the Japanese market is complex. Similar to the EU market, it is Japan’s sandbox; therefore, it is their rules that apply. In closing, the doctor hopes you will enjoy his new series on complying with Japanese Ministerial Ordinance 169. After all, Japan is the second largest device market. Until next week, when the doctor provides an overview of MO 169, cheers from Dr. D and best wishes for continued professional success.
- How to market medical devices in Japan. (2012). Retrieved June, 2012 from http://www.hbmsp.sipa.gov.tw:9090/itri/en/images/Legal6_2.htm
- Japan: market entry for medical devices. (2012). Kingdom of the Netherlands. Retrieved June 6, 2012, from http://www.agentschapnl.nl/sites/default/files/bijlagen/Japan%20- %20A%20Seven%20Step%20Approach%20to%20Market%20Entry.pdf
- Konishi, S. (2011 November). Japan’s medical device market and regulatory system.
Retrieved June 6, 2012, from http://albertacanada.com/japan
- Medical device registration in Japan. (2012). Emergo Group Website. Retrieved June 10, 2012, from http://www.slideshare.net/emergogroup
- Will you let slip the world 2nd largest medical device market? (2010). Retrieved June 8, 2012, from http://www.asiaitc.com/download