"Global Certification Process Of
Medical Devices"

By Mr. Guruprasad H.C.
 

"Exploring regulations of various countries on Medical Devices"

Manufacturers who wish to access these global markets for medical business need to follow and comply against the set rules and regulations set by individual countries.

The Medical Devices market is increasingly global and regulations are constantly evolving. Working with an experienced and recognized Notified Body can guide your organization through the regulatory requirements can bring confidence and many benefits to manufacturers.

In this seminar we learn and understand the “Regulations of various countries on Medical Devices”

CE Mark
 
CE marking is a legal requirement for Medical Devices intended for sale in Europe. Medical Devices sold within the European market must have CE Marking affixing to identify claims of safety and compliance with regulatory mandates. The European Union strictly controls the use of CE Marking on Medical Devices. To affix CE Marking, manufacturers may need to work with a recognized Notified Body, to confirm compliance with European regulation

Learn on Classification rules of Medical devices and process for CE Marking accordance to Directive MDD 93/42/ EEC - Medical device and 98/79/EC -in vitro diagnostic medical devices
Implementation of For Quality Management System, the international standard ISO 13485 is an independent standard and was designed for companies in the medical devices sector. And building the Technical file on Medical product

PAL- QMS / GMP Certifications process for access Japan Market
 
Manufacturer needs to show compliance against QMS/GMP Audit and certification in accordance with MHLW ordinance No. 169, as set by , Ministry of Health, Labor and Welfare (MHLW)

Premarket Notification 510(k) and third party review process

Premarket notification (PMN) submissions [510(k)]s for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the FDA.
The Office of Device Evaluation (ODE) within CDRH is responsible for the processing and review of 510(k)s and providing a decision related to clearance to market medical devices in the U.S.

Requirements of other major countries, like China, health Canada and Other.

Guruprasad. H.C

Qualified Medical Auditor from TVU Rheinland, with past experience over 15 years in Medical equipment Manufacturing industry. In the areas Production, Product safety testing, Engineering, Product Design and Safety and Regulatory engineering (SRE) and Management representative.

Mr. Guruprasad
TÜV Rheinland (India) Private Limited