Medical Devices

Pharmaceutical and Medical Device Act

Medical devices are regulated by the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (hereinafter referred to as “the Pharmaceuticals and Medical Devices Act) , which came into effect in November 2014.

Market Authorization in Japan:

In Japan, a person who intends to market specially controlled medical devices, controlled medical devices or in vitro diagnostics  is to be certified for each product by certification bodies registered by the Minister of Health, Labour and Welfare based on Ministerial Ordinance.”

Foreign Manufacturers

Foreign Manufacturers must designate a marketing authorization holder to market Medical Devices.

GRP Regulatory Services in Japan:

Global Regulatory Partners Inc. GRP, is an MAH holder in Japan and has a team of local experts in Tokyo who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in Japan’s market.

More Resources:

Authorized local agent

Authorized Local Agent in Japan (MAH)

Pharmaceuticals and Medical Devices Agency (PMDA) require all foreign Pharmaceutical and Biologic companies to assign a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) before registering and selling their products in Japan. In Japan.

GRP Japan office is licensed by PMDA as a Category I MAH and can act as your MAH in Japan.

GRP-Japan MAH Services:

  • Communication with the PMDA
  • Assistance with PMDA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support PMDA consultation meetings
  • Product registration
  • Product storage in an establishment with MAH licensing
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner. At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence  for Japan that includes the latest  PMDA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs.

Regulatory Strategy

Defining the correct regulatory strategy is becoming very challenging as the regulatory landscape keeps changing constantly changing and new technologies are being introduced all the time. Following the correct regulatory strategy is crucial for Medical device companies during their product development through commercialization, as it helps them register their products successfully with MHLW and PMDA health authorities and bring them to the market with minimum risk. Global Regulatory Partners Inc. (GRP) team in Japan has helped many companies explore various regulatory options and develop optimal and efficient regulatory strategies for their medical devices and IVDs for Japan’s market.

GRP regulatory strategy services :

  • Identify and the latest regulatory requirements related to your medical device or IVD.
  • Proactively identify challenges or issues that may delay the approval of your medical device in Japan.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your medical product registered in Japan.

Regulatory Affairs

Global regulatory Partner, Inc. (GRP), provides a full regulatory affairs service in Japan from product concept product development and product registration. Our Local Regulatory affairs team in Tokyo can  help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Our regulatory affairs services in Japan include:

  • regulatory intelligence,
  • regulatory strategy,
  • regulatory operations,
  • and publishing;
  • product registration,
  • registration amendments;
  • consulting meetings with the PMDA and MHWL  authorities.

Product registration

Before legally selling a medical device on the Japanese market, it must comply with the regulatory requirements of the Pharmaceutical and Medical Device Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW). Classification dictates the regulatory procedure for the devices, so it is crucial to determine the correct classification and product code for the device before beginning its registration process.

The registration pathway for medical devices or IVDs is determined by their classification and associated Japan Medical Device Nomenclature

Medical Device Classification:

In Japan, Medical devices are classified based on the risk to the human body. PMDA uses the following classification system for medical devices:

  • General-CLASS I (low risk)
  • Specified Controlled-CLASS II (low/medium risk)
  • Controlled-CLASS II (medium risk)
  • Highly Controlled-CLASS III (medium/high risk)
  • Highly Controlled-CLASS IV (high risk)

Japan Medical Device Nomenclature (JMDN codes):

MHLW maintains a database of generic medical device descriptions with associated Japan Medical Device Nomenclature (JMDN) codes. This system is similar to the US FDA system of product codes or Global Medical Device Nomenclature (GMDN) system. Familiarity with the JMDN database and fluency in Japanese are essential to determine the device’s code.

If a code of a new device does not exist, the product must go through a new device pathway, and its classification is determined based on its risk according to the classification rules in Yakusyokuhatsu No. 0720022. However, the final determination of the device classification is made by the MHLW.

Medical Device Premarket Pathways: 

Pre-market submission (Todokede)

General Medical Devices (Class I) are subject to a pre-market submission that need to be file to the PMDA. This is a notification and no review assessment by the PMDA will be conducted.

Pre-market certification (Ninsho)

Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre-market certification. Many, but not all, Japan Industrial Standards are based on existing ISO/IEC standards. The MAH/DMAH files the application with a Registered Certification Body (RCB). The process is similar to the European CE Marking process where reviews are outsourced to authorized third parties such as Notified Bodies.

Pre-market approval (Shonin)

Class II and III medical devices without a specific certification standard, are subject to the pre-market approval process. This also applies to all Class IV devices. In this case the MAH/DMAH will file a pre-market approval application with the PMDA and ultimately obtain approval from the MHLW.

Registration of MD Process in Japan:

Global Regulatory Partners Japan has helped many companies register successfully their medical devices and IVDs products in Japan.

GRP Product Registration Services:

  • Act as your Market Registration Holder (MRH)
  • Determine classification of your device
  • Help you determine the proper regulatory pathway for your device
  • Inform you of the documentation required within the applicable registration route.
  • Help you determine a grouping strategy for your registration
  • Prepare and submit registration application documents to PMDA
  • Coordinate translation of submission materials into Japanese
  • Work to answer questions from PMDA during the submission process

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Japan. As Regulatory authorities (MWHL and PMDA) expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc. (GRP), has a team of professional medical writers in Japan who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Medical writing | Global Regulatory Partners

Health authority consultation

Consultation meetings with the MHWL and PMDA  can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan. GRP-Japan regulatory affairs team has organized and supported  numerous PMDA consultation meeting  for medical device products.

Global Regulatory Partners Inc., (GRP) regulatory affairs team in Tokyo has the expertise in preparing consultation meeting with PMDA heath authorities before starting key milestone of your product.

 

GRP- Japan regulatory affairs team supports includes:

  •  writing 
  • preparation and submission of the meeting package to the health authority,
  • prepare the questions to health authority based on the status of your product’s development and future plan,
  • provide support during the meeting,
  • write the meeting minutes and develop the appropriate action plan after the consultation meeting. 

Clinical

Our professionals apply their therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and PMDA and MHWL regulatory requirements. In an increasingly challenging environment, GRP- Japan has developed the experience and knowledge to find, recruit, and retain patients in clinical trials. We can successfully deliver access to the appropriate sites and patients, developing strategies that will minimize the risks inherent in-patient recruitment.

Global Regulatory Partners Japan has helped many companies conduct successfully their clinical trials for their medical devices or IVDs in Japan. 

Global Regulatory Affairs clinical services:

  • Protocol development
  • Site and investigator identification and qualification
  • Site initiation and training
  • Clinical monitoring
  • Medical monitoring
  • DSMB coordination
  • Statistical analysis
  • Electronic data capture
  • Electronic Trial Master File
  • Full-service data management
  • gov registration and management
  • Central lab oversight and coordination
  • Site quality assurance audits
  • Integrated final Clinical Study Report

Quality

Overview:

According to the PMD Act, manufacturing facilities are subject to a Quality Management System (QMS) conformity assessment as part of the Japanese registration process. QMS conformity assessments are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) or a Registered Certification Body (RCB). Foreign manufacturers who have chosen the Foreign Special Approval System route and hold pre-market approvals (Shonin) or certifications (Ninsho) will undergo QMS conformity assessments. Foreign manufacturers must appoint a Designated Marketing Authorization Holder (D-DMAH) to represent them in Japan.

QMS conformity assessment certification

Upon successful completion of a QMS conformity assessment, a MAH or manufacturer is issued a Certificate of QMS Conformance (Kijun Tekigoshou) by either the PMDA or RCB. Certificates of conformance are valid for five years and include the registered product name, product group (Seihingun), and manufacturing facility. Under the PMD Act, future conformity assessments focus on devices from the same product group registered with the PMDA or RCB, rather than the manufacturing facility.

QMS Inspection:

  • QMS (MHLW Ordinance No. 169 in 2004, MHLW Ordinance No. 94, 2014)
  • QMS compliance inspection can be performed either on desktop/document or  on-site

Figure 1: QMS Inspection Process

GRP Japan Quality services:

  • Review your quality manual and prepare a gap analysis with references to the appropriate clauses of Ordinance #169.
  • Create and propose changes needed to comply with the Japan QMS regulation, including preparation of the Device Master File.
  • Prepare supplemental documents as an appendix of the quality manual.
  • Conduct a mock audit of your quality system prior to your PMDA conformity assessment.
  • Prepare and submit the QMS Conformity Assessment application on your behalf.
Global Regulatory Partners Japan has helped many medical devices and IVD companies implement and comply with QMS in Japan in line with Ordinance #169. 

Japan

Pharmaceuticals

GRP Pharmaceutical Services:

Global Regulatory Partners, Inc. (GRP), provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in Japan. Our regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management.

Through our local office in Tokyo, GRP-Japan can act as your local authorized agent in Japan and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.

More Resources:

  • “Read More” to acess more information on Pharmaceuticals in Japan
  • GRP Presentation. Drug Master File (DFM) Registration in Japan
  • GRP Presentation. GRP company capabilities in Japan.

Authorized local agent

Pharmaceuticals and Medical Devices Agency (PMDA) require all foreign Pharmaceutical and Biologic companies to assign a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) before registering and selling their products in Japan.

GRP Japan office is licensed by PMDA as a Category I MAH and can act as your MAH in Japan.

GRP local agent (MAH) Services in Japan:

  • Communication with the PMDA
  • Assistance with PMDA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support PMDA consultation meetings
  • Product registration
  • Product storage in an establishment with MAH licensing
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

Japan’s Pharmaceutical Market:

Japan is the third-largest drug market in the world.  In 2019, the pharmaceutical market size in Japan was worth $95 billion. The growth of the Japanese generics drug market is the most interesting, in less than a decade ,  its market worth doubled and was valued at approximately $ 1.66 trillion Japanese yen, in 2018. Currently, the Generics market  represent 80% of the pharmaceutical market and  have been continuously growing since the government started to promote their use in 2007.

GRP RI Services in Japan :

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence  for Japan that includes the latest PMDA and MHWL regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in different markets.

Regulatory Strategy

Navigating the regulatory system in Japan is very challenging as Japan has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient regulatory strategy to obtain approval for your pharmaceutical product in Japan is key for your success in Japan. Global Regulatory Partner GK Regulatory Team in Japan has many years of experience working within PMDA and within the Japanese regulatory environment and can help you define the appropriate regulatory strategy for your product in Japan. Our regulatory team will help you with the following:

GRP regulatory strategy services in Japan:

  • Identify the latest regulatory requirements related to your drug in Japan.
  • Proactively identify challenges or issues that may delay the approval of your drug in Japan.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your drug registered in Japan.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development, registration,  commercialization in Japan

GRP- Japan regulatory affairs services include:

  • Regulatory Intelligence (RI),
  • Regulatory Strategy,
  • Regulatory operations and publishing,
  • Product’s registration,
  • Products’ life cycle management and maintenance.