Nami Device Advisors
National Alliance on Mental Illness (NAMI)
NAMI is the nation's largest grassroots mental health organization, offering support, education, and advocacy for individuals and families affected by mental illness.
The National Alliance on Mental Illness (NAMI) is the nation's largest grassroots mental health organization dedicated to building better lives for the millions of Americans affected by mental illness. NAMI provides essential education, advocacy, support, and public awareness programs. They offer resources for individuals seeking help, families looking for support, and those interested in advocating for change in mental health policy and access to care. Their work focuses on promoting recovery, improving community services, and fostering understanding and acceptance of mental health conditions.
About
**Who they are**
Nami Device Advisors is a specialized consultancy focused on supporting medical device manufacturers navigating the Japanese regulatory landscape. They act as a crucial link for companies seeking to market their devices in Japan.
**Expertise & scope**
* Expertise in Japanese Medical Device Regulations (PMDA).
* Services tailored for MAH (Marketing Authorization Holder) and DMAH (Designated Marketing Authorization Holder) requirements.
* Support for navigating the regulatory pathways specific to the Japanese market.
**Reputation / proof points**
* Coverage specifically for Japan (JP).
Nami Device Advisors is a specialized consultancy focused on supporting medical device manufacturers navigating the Japanese regulatory landscape. They act as a crucial link for companies seeking to market their devices in Japan.
**Expertise & scope**
* Expertise in Japanese Medical Device Regulations (PMDA).
* Services tailored for MAH (Marketing Authorization Holder) and DMAH (Designated Marketing Authorization Holder) requirements.
* Support for navigating the regulatory pathways specific to the Japanese market.
**Reputation / proof points**
* Coverage specifically for Japan (JP).
Additional information
Engaging with Nami Device Advisors requires understanding the specific nuances of Japanese regulatory submissions. Buyers should be prepared to provide detailed technical documentation for their devices. The firm's focus on the Japanese market means they are well-versed in local requirements, including labeling and submission formats. Their language capabilities in Japanese, English, and Chinese can facilitate smoother communication with both the regulatory bodies and the client's internal teams.
Key Highlights
- Facilitates PMDA communication workflows and deadline management for regulatory submissions Source
- Provides translation support for essential documents including labels, Instructions for Use (IFU), and technical/regulatory dossiers Source
- Assists with MAH/DMAH appointments and clearly defines responsibilities between parties Source
- Offers support for GMP/QMS coordination to ensure readiness for audits Source
Certifications & Trust Signals
- Demonstrated experience in managing regulated lifecycle documentation for medical devices and IVDs Source
- Established operational escalation process for addressing critical regulator deadlines and urgent inquiries Source
- Supports multi-language communication needs for international teams, adaptable to specific project requirements Source
Buyer Snapshot
Best for
- Medical device manufacturers seeking Japanese market entry.
- Companies needing local MAH/DMAH representation.
- Firms requiring assistance with PMDA submissions.
How engagement typically works
- Consultative and advisory.
- Facilitates communication with regulatory bodies.
- Requires detailed technical documentation from the client.
Typical deliverables
- MAH/DMAH services.
- Regulatory strategy advice.
- Submission dossier preparation.
- Liaison with PMDA.
Good to know
- Best when clients have comprehensive device technical files ready for submission.
HQ:
Hiroshima, US
Languages:
Japanese, English, Chinese
Timezones:
Asia/Tokyo
Status:
listed
Services & Capabilities
Japan MAH / DMAH Services
Jurisdictions:
JP
Countries:
JP
Industries:
Medical devices, IVD, Life sciences
Portfolio:
26-100
Onboarding time:
7–30 days
Pricing model:
Onboarding + annual retainer
Starting from:
USD 12,000
Included services:
MAH/DMAH appointment support, PMDA liaison and communications routing, Local license/establishment maintenance support, Translation enablement (scope-dependent), GMP/QMS coordination support (scope-dependent)
Offers MAH:
Yes
Offers DMAH:
Yes
PMDA Support:
Yes
Languages:
Japanese
Local License Capability:
Yes
Translation Support:
Yes
GMP Qmssupport:
Yes
Regulatory Liaison PMDA:
Yes
Additional jp_mah_dmah Details
Included Services Detailed
MAH/DMAH onboarding and mandate setup (seed scope), PMDA liaison and communications routing (seed scope), Local license/establishment maintenance tasks (seed scope), Translation enablement for core regulatory documents (seed scope), GMP/QMS coordination support for audit readiness (seed scope)
Excluded Services
Manufacturing or supply chain execution, Acting as commercial distributor by default, Legal representation in disputes or litigation
Onboarding Steps
Onboarding involves providing detailed technical information about the medical devices, including design history files, risk management documentation, and manufacturing process details, to facilitate dossier preparation and submission for market authorization.
Service Notes
This seed profile is unverified and intended for initial directory population.
Offers MAH
Yes
Offers DMAH
Yes
PMDA Support
Yes
Regulatory Liaison PMDA
Yes
Translation Support
Yes
