To help manufacturers to rule out confusing regulatory approvals, the Pharmaceuticals and Medical Device Agency (PMDA) offers meetings to answer manufacturer´s consultations. The reason for this benefit is that the PMDA wants all multinational manufacturers, who want to distribute in Japan, to know and understand all the regulations before submitting an approval application.

These are the more important types of consultations for medical devices:

-       Consultation before and during the R&D phases

-       Consultation about the need for the clinical study

-       Consultation about the requirements and evaluation of : (i) Safety, (ii) Quality, (iii) Performance, (iv) Exploratory Clinical Trial, and (v) Clinical Trial

-       Consultation about the documents submitted and submission category

-       Consultation about clinical trial expansion

These are the more important types of consultations for IVD:

-       Consultation about different types of meetings

-       Consultation about IVDs pre-developments

-       Consultation about companion diagnostics pre-developments

-       Consultation about requirements and evaluation of: (i) Quality, (ii) Performance (other than Quality), (iii) Correlativity, (iv) Clinical Performance Tests, and (v) Clinical Performance Tests for CoDx

-       Consultation about the submission process

After these meetings, if any manufacturer needs further recommendations a new consultation could be held.

Sources: NAMSA < https://www.namsa.com/asian-market/japans-pmda-consultation-offering/​ >