What is BSI's role in market access in Japan?
We are one of four Registered Certification Bodies (RCB) that is authorized to conduct certifications by the MHLW for all types of Class II Designate Controlled Medical Devices and In-Vitro Diagnostic Reagents. We also provide a number of solutions for our global customers wishing to access the Japanese market, including MDSAP auditing as a recognized Auditing Organization (AO). So as your company grows and expands sales into overseas markets, we can support your regulatory needs, allowing you to meet the increasingly complex regulatory schemes and certifications.
Streamlined audits can help save you money
We have auditors qualified to conduct MO 169 audits in Asia, Europe and the Americas, and can combine the required PMD Act audits with our clients’ ISO 13485 and Notified Body audits, streamlining the process. And to save you from additional audits, our reports covering ISO 13485 and MO 169 are accepted by other RCBs for use in conjunction with their reviews of product submissions from their Market Authorization Holder (MAHs).
Supporting smaller companies with global market access
Newly established or smaller companies may have a challenge obtaining a Japan-based Market Authorization Holder (MAH) with QMS & GVP capability to hold the marketing approval. Japan has harmonized the QMS requirements with ISO 13485, but there are additional requirements that will fall under the responsibility of overseas manufacturers under Ministerial Ordinances’ requirements for accreditation. With experience working with companies of all sizes, we have the expertise to support you as you break into this highly regulated yet profitable overseas market.
Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: