Free ISO 13485 Control of Documents Template
Free ISO 13485 Control of Documents Template Free ISO 13485 Control of Documents Template Use the link below to download this template. If the link does not work, email us here…
Vietnam: No: 5159/ BYT-TB-CT Implementation of Medical Equipment prices disclosure
5159/ BYT-TB-CT Summary and Interpretation On the 28th Sep 2020, DMEC has just issued a letter on making public the price of medical equipment in a government portal. Please see…
Medical Device Registration in Taiwan
Medical Device Registration in Taiwan Click here to visit the Taiwan FDA (authority) website. Requirements for QSD (Good Manufacturing Practice): 1. Quality Manual 2. SOP list 3. ISO 13485 certificate…
IMDRF 2020
IMDRF 2020 Source HSA: About the IMDRF The International Medical Device Regulators Forum (IMDRF) comprises a group of regulators that come together to drive medical device regulatory harmonisation and convergence.…
Easy Guide on how to comply to MDR and ISO 13485
Introduction: Easy Guide on how to comply to MDR and ISO 13485 "Easy Guide on how to comply to MDR and ISO 13485" is aimed to provide first the…
How to choose an EC REP
How to choose an EC REP This article on how to choose an EC REP applies to Authorized Representative, Sponsor or Consultant too. Please click here to access the European commission…
New Zealand: Medical Device Registration in New Zealand
Medical Device Registration in New Zealand Click here to visit New Zealand Medsafe website. Requirements as below: Technical File summary Essential Requirement Checklist Risk Management File Usability Report Clinical Evaluation…
Medical Device registration in the US
Medical Device Registration in the US Background for medical device registration in the US The Federal Food, Drug, and Cosmetic Act (FD&C Act)—as amended by the Medical Device Amendments of…
Cambodia: Medical Device Registration in Cambodia
Medical Device registration in Cambodia Click here to visit Cambodia DDF (Authority) website. Cambodia’s Department of Drugs and Food (DDF), which is part of the Ministry of Health, is the…
How to do Clinical Evaluation Report
How to do Clinical Evaluation Report: MDCG 2020-13 One way to ensure that your CER is complying to CE requirements is to ensure that that your CER contain all the…
