Medical Device Certification, Approval and PAL Compliance Consulting
Emergo Group helps medical device companies obtain certification or approval to sell their medical devices in Japan. Through our offices in Tokyo, we can guide you through the complex Japanese Pharmaceutical Affairs Law (despite the name, PAL applies to medical devices) and corresponding registration process so you can gain access to this lucrative market, the third largest in the world behind the US and Europe.
For foreign manufacturers, complying with Japan's Pharmaceutical Affairs Law (JPAL) of 2005 can be challenging. Few English language documents have been issued by the Ministry of Health, Labour and Welfare (MHLW) and its division, the Pharmaceutical and Medical Devices Agency (PMDA). Language barriers and a complex registration process make Japan one of the most difficult and time consuming markets for medical device manufacturers to enter.
Let Emergo help you with Japan PAL compliance and medical device approvals:
- Quality systems modification or implementation to comply with Japan's quality system requirements in MHLW Ministerial Ordinance 169.
- Medical device classification and registration.
- Medical device Approvals (Shonin), Certifications (Ninsho) and Submissions (Todoke)
- Designated Marketing Authorization Holder (D-MAH) representation.
- Accreditation of Foreign Manufacturer application.
- Coordination of inspections by the Pharmaceutical and Medical Devices Agency (PMDA).
- Audits and gap analyses prior to Certification Body assessments.
- Registered Certification Body (RCB) selection and coordination.
- Completion of application forms #64 and #67.
- Medical device reimbursement consulting.
- Distributor search and management.
- Documentation translation into Japanese.
Please contact us for more information on obtaining medical device certification (ninsho) or approval (shonin) in Japan.
