Regulatory Affairs Expertise

Our regulatory consultants have a wide range of expertise in Medical Device specialties, including consulting on regulatory issues to determine if a product is categorized as a Medical Device, and to assist with classification. Our experts can prepare registration documentation for Class I Medical Devices (Todokede: pre-market notification), Class II devices (Ninsho: pre-market certification), and Class III and IV devices (Shonin: pre-market approval), as well as documentation for clinical trials.
We can also provide support for in vitro Diagnostics (IVD). Our expertise includes genetic tests (including NGS + Oncology panel) and combination services for simultaneous product development of drugs and IVD test (i.e., a companion diagnostic). Our IVD regulatory consultants are equipped to discuss business strategies for biotechnology products.
In addition to providing regulatory support in Japan, we can also provide support in China, Korea, Taiwan, Hong Kong, Singapore, Malaysia, Thailand, Vietnam and the Philippines. Our resources include the ability to work for US and European biopharmaceutical customers.

Our Edge in Medical Devices and IVD

Development of new concepts in collaboration with CMIC’s pharmaceuticals/ regenerative medicine consulting division

  • We can provide combination services for simultaneous product in two different domains, such as a drug and a medical device (e.g., drug eluting stent and a drug injector) , a healthcare product or a tissue-engineered medical products and a medical device or a drug and an IVD test (e.g., companion diagnostic agent).

Experience in consulting on regulatory issues for the latest medical devices

  • Our team has expertise supporting medical devices, such as heart analysis software, cerebral blood vessel stents, stent grafts, etc.
  • We also are skilled with supporting IVD products. We have supported a significant percentage of oncology panels and companion diagnostics in Japan.

Services

– Medical Device

Medical Device Registration Business LicenseExporting outside of JapanExporting to Japan
Regulatory consulting, including classification of Medical Devices and need for clinical trialAssistance in obtaining Marketing Authorization Holder and Manufacturing licensesObtaining CE Marking for export of medical devices outside of JapanType 1 Marketing Authorization Holder Business License (#13B1X10146)
Preparation for MHLW and PMDA consultation meetingOrganizational structure consulting for ISO13485 QMS requirementsObtaining 510(k) clearances and premarket FDA approvals

Medical Device registration assistance

Negotiations with MHLW and writing work for reimbursement

Planning and writing related to PMS

Documentation supportAudit support for domestic and foreign manufacturing facilities

Provides

Designated Marketing Authorization Holder (dMAH) services

– IVD

  • Consulting on biotechnology business strategies
  • Companion diagnostics
  • Oncology panels for NGS
  • Tests for viruses
  • Immunohistochemistry protein biomarkers
  • Predictive genetic markers for administration of anti-tumor agents
  • Infection (bacterial) protein biomarker

Marketing Authorization Holder (MAH)

Regulatory Consulting

Consulting Services

Laboratory Services

Regenerative Medicine