Global Regulatory Pulse

The Three Pathways to Medical Device Registration in Japan

In Asian Market, Regulatory by Chikako Kitayama

The medical device industry in Japan is one of the most attractive markets in the world, and has undergone tremendous growth in the last several years. In fact, this geographic marketplace has experienced consistent growth over the last 20 years with an annual growth rate (CAGR) of 4.8 percent from 2011-2016, and a 6.7 percent CAGR for imported products during the same time period. In total, the Japanese medical device industry is predicted to reach $2.6B USD by the close of 2016.

There are several reasons why this geographic location is in high-demand, including the variety of pathways available for medical device registration, which include: Shonin (Approval), Ninsho (Certification) and Todokede (Notification). The required registration process is dependent on the classification of a particular medical device, and the timeline largely differs based on the pathway utilized (risk-based).

Japanese classifications fall into one of four categories, ranging from Class IV (high risk) to Class I (low risk). To help illustrate these classifications, the table below was created.

 

Classification

Medical Device Examples
Class IV Artificial cardiac valve, cardiac pacemaker, PTCA catheter, cardiac stent, implantable artificial heart, radiation brachytherapy device
Class III Artificial lung, cardiopulmonary bypass circuit, suture, artificial joints, ventilator, lithotripsy, particle beam therapy system
Class II X-ray CT, ECG, ultrasonic diagnostic equipment, electrosurgical knife, electric massagers (home use), dental chair, high-pressure steam sterilizer
Class I Scalpel*, forceps*, plaster cast, aspiration device, X-ray radiation treatment table, operation microscope

*Only unsterilized; single use sterilized products fall under Class II.

Class Breakdown

  • Class IV, and the majority of Class III devices, require the Shonin process.
  • Most Class II devices, and a few Class III devices, follow the Ninsho pathway. Class II products that do not hold, or comply, with the Ninsho Certification Standard can be approved via the Shonin pathway.
  • Finally, Class I devices only require registration via the Todokede process.

It is important to note that Shonin and Todokede processes are controlled by the Pharmaceutical and Medical Device Agency (PMDA), an administrative agency related to the Ministry of Health, Labor and Welfare (MHLW). One significant difference between the two pathways is that Todokede does not require a review process, whereas Shonin’s required review process can involve long timelines, sometimes taking in excess of a year. Additionally, if the PMDA accepts a Todokede application form, the associated product can immediately be marketed.

Ninsho, requiring a review period, typically has shorter timelines, with an average of three months. This pathway also requires a private Registered Certification Bodies responsibilities in accordance with the Pharmaceutical and Medical Device Act. There can be large differences in timelines between Shonin, Ninsho and Todokede, as well as many advantages and disadvantages to all categories.

If you would like to learn more about the most efficient pathway to market for your medical device in Japan, we invite you to speak with our experts who have deep knowledge related to all Japanese registration pathways. We invite you to contact us here.

Reference: http://www.jfmda.gr.jp/device/industry/

 

 

Authors:

Chikako Kitayama currently serves as Medical Research Manager for NAMSA-Japan.