Medical Devices & IVD

Medical Devices and in vitro Diagnostic Consulting: 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 + CGP (Comprehensive Genome Profile) 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 Korea, Taiwan, Hong Kong, Singapore, Malaysia, Thailand and the Philippines. Our resources include the ability to work for US and European biopharmaceutical customers.

Our Edge in Medical Devices & IVD

Medical Device Testing Solutions IVD Support CMIC Group

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 a high level of expertise supporting various kinds of medical devices especially in high-risk and/or state-of-the-art products. Recently we have been providing more support for SaMD (Software as a Medical Device) development.
We also are skilled with supporting IVD products. We have supported a significant percentage of oncology panels and companion diagnostics in Japan.

Medical Device Services

Medical Device Registration	Business License	Exporting outside of Japan	Exporting to Japan
Regulatory consulting – Feasibility study, consultation on strategy and timeline	Assistance in obtaining Marketing Authorization Holder and Manufacturing licenses	Obtaining CE Marking for export of medical devices outside of Japan	Type 1 Marketing Authorization Holder Business License (#13B1X10146)
Preparation for MHLW and PMDA consultation meeting	Organizational structure consulting for ISO13485 QMS requirements including MDSAP	Obtaining 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 support	Audit support for domestic and foreign manufacturing facilities		Designated Marketing Authorization Holder (dMAH) Services* *CMIC will review project internally to determine acceptance of high-risk products