Japan Regulatory Affairs, Clinical, Safety and Quality Consulting for Medical Devices and Pharmaceuticals

MARKET OVERVIEW

Japanese healthcare market is one of the most successful markets across the globe. It is established and is growing continuously . The healthcare sector in Japan is more focused toward the elderly population because the country has the highest number of geriatric population in the world. The policy to reduce the length of hospital stay and shift the treatment to home care centers is one of the major agendas of Japanese healthcare reform. The healthcare authorities in Japan provide less co-pay for the treatment of patients aged 75 years and above. Further, the government in Japan has taken initiatives to reduce device lag and accelerate the approval process, which provides an opportunity to foreign vendors to tap the market in Japan. The strong IP protection by the government in Japan for innovative products has created an opportunity for the launch of novel products in the country.

JAPAN REGULATORY AUTHORITY

In Japan there are two regulatory bodies that regulate medical devices and pharmaceuticals :

Ministry of Health, Labor, and Welfare (MHLW)

The MHLW is Japan’s primary regulatory body for creating and implementing safety standards for medical devices and drugs. Within the MHLW, the Pharmaceutical and Food Safety Bureau is in charge of pharmaceutical and medical device regulatory policy. The MHLW’s responsibilities in policies and administrative measures include:

• Final judgment on registration approval
• Product withdrawal from the market

Pharmaceutical Medical Devices Agency (PMDA)

The PMDA is an independent administrative agency that works with the MHLW to ensure the safety and quality of drugs and medical devices in Japan. The PMDA is the “technical arm” of the MHLW. The PMDA’s responsibilities in assisting the MHLW’S measures include:

• Review and Approval of medical devices and pharmaceuticals
• QMS/GLP/GCP inspection
• Collection and analysis of Adverse Event Reports

For more information on MHLW, check the website link at: http://www.mhlw.go.jp/english/

For more information on PMDA, check the website link at: https://www.pmda.go.jp/english/

MEDICAL DEVICE CONSULTING IN JAPAN

Before marketing their products in Japan, medical device and IVD companies must register their products and manufacturing site with Pharmaceuticals and Medical Device Agency (PMDA) and obtain a Quality Management System (QMS) certification from PMDA as well. Additionally, foreign companies, with no presence in Japan, must appoint a local Marketing Authorization Holder (MAH) that can handle all their regulatory and compliance activities in Japan.

Global Regulatory Partners Japan “One-Stop Shop” for all your regulatory affairs, quality, safety and clinical needs in Japan

Global Regulatory Affairs provides the following services in Japan:

• Regulatory Strategy
• Foreign Manufacturer Accreditation Licensing (FMA).
• Product Classification
• Medical Device and IVDs Registration
• Quality Management System (Ordinanance#169) compliance.
• In-Country Representation in Japan ( MAH)
• Clinical Trials.
• Products reimbursement.