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 with regulatory compliance in Japan. They act as a crucial link between device companies and the Japanese regulatory landscape.
**Expertise & scope**
* Navigating Japanese regulatory requirements for medical devices.
* Providing guidance on compliance with the Pharmaceuticals and Medical Devices Agency (PMDA).
* Facilitating market access for medical devices in Japan.
**Reputation / proof points**
* Coverage: Japan (JP)
Nami Device Advisors is a specialized consultancy focused on supporting medical device manufacturers with regulatory compliance in Japan. They act as a crucial link between device companies and the Japanese regulatory landscape.
**Expertise & scope**
* Navigating Japanese regulatory requirements for medical devices.
* Providing guidance on compliance with the Pharmaceuticals and Medical Devices Agency (PMDA).
* Facilitating market access for medical devices in Japan.
**Reputation / proof points**
* Coverage: Japan (JP)
Additional information
Engaging with Nami Device Advisors requires understanding the specific nuances of the Japanese regulatory environment. Buyers should be prepared to provide detailed technical documentation for their devices. The firm's expertise is particularly valuable for companies unfamiliar with PMDA submissions and local compliance obligations. Their services are designed to streamline the process of obtaining market authorization, ensuring that devices meet all necessary safety and efficacy standards for the Japanese market.
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
- Companies seeking to enter or expand within the Japanese medical device market.
- Manufacturers needing expert guidance on PMDA regulations.
How engagement typically works
- Consultative support for regulatory strategy.
- Facilitation of communication with Japanese authorities.
Typical deliverables
- Regulatory compliance assessments.
- Guidance on submission requirements.
- Support for market authorization.
Good to know
- Best when focused on the Japanese market.
HQ:
Hiroshima, US
Languages:
Japanese, English, Chinese
Timezones:
Asia/Tokyo
Claim 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
Requires detailed technical documentation for medical devices to support regulatory submissions and compliance.
Service Notes
This seed profile is unverified and intended for initial directory population.
Offers MAH
No
Offers DMAH
No
PMDA Support
Yes
Regulatory Liaison PMDA
Yes
Translation Support
Yes
