Medical Device Registration

We JNM Global is your trustful and specialized Medical device registration consultant for “WORLDWIDE” registration 

JNM Global

Medical Device Consulting Service

JNM Regulatory Compliance team is professional expert of Medical Device Registration Consulting service in Global Market.

Our Regulatory Compliance Team can assist complex medical device registration of each of countries with turn key service from beginning of documents preparation, Submission, follow up for authority feedback and including device test, QMS inspection, etc.

Our team can handle and have experience of various Medical device compliance, not only for the active device but also the non-active, invasive, implantable, aesthetic device regardless of Classification.

 

20+ Global Registration Consulting

Global Representative Service

Medical Device Testing by internal Laboratory with CB Scheme

QMS Consulting with inspection

Cost effective with fast feedback

Medical Device Definition

Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material or other similar or related intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

  • diagnosis, prevention, monitoring, treatment or allevi­ation of disease,
  • diag­nosis, monitoring, treatment, alleviation of or com­pensation for an injury,
  • inves­tigation, replacement, modification, or support of the anatomy or of a physiologi­cal process,
  • supporting or sustaining life,
  • con­trol of conception,
  • disinfection of medical devices,

 

What is Local Representative ?

In Global Market Access for medical devices, most of countries request the local agent who can submit the medical device registration application to authority or 3rd party review agency.

We call this Company as “Local Representative” for each countries. Sometimes Local representative shall be a importer (ex. South Korea, Japan) or can be the license holder who is not involving in importation procedure (ex. Australia, Saudi Arabia).

First step for Global entrance is finding good partner who can provide the license holding for each of markets.

JNM Global 

Medical Device Consulting Scope

 

Regulatory Strategy

As medical device consultant, we provide the regulatory strategy for each of markets to proceed smooth registration. Most of countries have their own regulatory pathway and JNM Global can be your trustful partner to make time efficient registration.

Local Representative Service

Many countries request for local representative, who can submit the medical device application to authority and holding the license.

Having trustful partner in each of countries is most important as they will be your license holder. JNM Global can assist the LR service as your global partner.

 

Device testing

We have our own laboratory who can perform the device safety testing + EMC testing for active medical devices.

Our Laboratory is accrediated as CBTL, so we can provide the CB test report for IEC60601-1 series. Feel free to contact for the testing service of JNM Global.

 

QMS Inspection

Some Countries are enough for ISO13485 certification but some are not. JNM Korea can assist the local QMS standard like 21 CFR Part 820, KGMP, BGMP, QMS of PMDA, etc.

We have internal ISO13485 auditor who can proceed the auditing and issue the certification.

 

Translation

We can provide Documents translation service in multiple languages with reasonable price. As many countries are requesting specific dossier in their own language, please feel free to contact JNM Global for local translation service.

Others

We can provide surveillance audit, Supplier audit, reimbursement or any other services relating to medical devices.