What is Japanese PMDA Registration?
If you are a medical device manufacturer interested in marketing your products in Japan, then you have to comply with the regulations of Pharmaceuticals and Medical Devices Act (PMDA).
Registration of a medical device in Japan is a complicated task as it involves a lot of difficult regulations to be adhered to. It might take at least 1 to 3 years to get it done, without enough expertise. Especially, if you are a foreign device manufacturer aiming at marketing your products in Japan, then this registration process will be a nightmare with language barriers adding on to it. This is because very few documents will be published in English. In spite of this, you can attain PMDA Registration for your device without any difficulty as our regulatory professionals have expertise in it and they can handle this entire process for you with ease.
Why is Japanese PMDA Registration Important?
In order to sell or import or distribute your medical device in Japan, you have to obtain PMDA Registration for your medical device. To acquire PMDA Registration, your medical device must comply with the quality management system ordinance "MHLW Ordinance No.169". You have to appoint a representative in Japan and perform the registration procedures.
How Can We Help?
We will classify your medical device as per the risk level and device classification norms
We will prepare the entire set of documents required for the following: (1) Pre-market Submission, (2) Pre-market Certification and (3) Pre-market Approval
We will help you observe the MHLW Ordinance 169 as well as ISO 13485
We also take care of the preparation of clinical support documents including clinical trials, clinical data, and protocol validity associated with the clinical trials
We are here to help you with the entire registration formalities. If you are planning for Japanese PMDA Registration for your device, then please contact us immediately to take it forward and together lets successfully complete the registration process!