TÜV Rheinland Blog - Stories from Asia and Africa

Planning to Enter the Medical Device Field in Japan? Get Familiar With the PMD Act

Posted by TUV Rheinland on Oct 11, 2018 3:33:28 PM

In November 2014, Japan enacted the Pharmaceutical and Medical Device Act, or PMD Act.

Officially called “The Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics”, the new law by the Ministry of Health, Labour and Welfare (MHLW) followed a thorough review and marked a substantial revision of the old Pharmaceutical Affairs Law (PAL).

Read More

Topics: compliance, medical devices, Japan

TÜV Rheinland India approved as a Notified Body by CDSCO, India

Posted by TUV Rheinland on Sep 26, 2018 10:17:45 AM

TÜV Rheinland India, a subsidiary of the TÜV Rheinland Group, Germany, a worldwide leader, that inspects technical equipment, products and services, oversees projects, and helps to shape processes and information security for companies, announced that It has been approved as a Notified Body by the Central Drugs Standard Control Organisation (CDSCO), India. TÜV Rheinland India will now be able to carry out audit of manufacturing sites of Medical Devices manufacturers as per Medical Devices Rules, 2017.

Read More

Topics: medical devices

What You Need to Know about the new ISO 13485 (2016) for Medical Devices

Posted by TUV Rheinland on Apr 17, 2018 4:49:44 PM
UweMeyer.png About the Author: Uwe Meyer
Certification Manager, TUV Rheinland Medical
Uwe is responsible for management of the Medical Devices Testing business unit, bringing with him 20 years of experience in regulatory product testing and certification. He additionally participates in business development, technical/industry committees and supports accreditation programs,  frequently speaking at conferences and webinars.

Did you know that as of February 28, 2019, the new revision of the ISO 13485 (2016) has to be used? This also means that as of the same date, the transition must be complete from ISO 13485:2003 and the associated European Standard EN ISO13485: 2012.

Read More

Topics: medical devices

How X-Ray Research Has Led to IEC Safety Standards

Posted by TUV Rheinland on Mar 16, 2018 2:27:38 PM

X-Ray: A Brief History

In 1895, German physicist, W.C. Roentgen discovered the X-ray. He found that the right mixture of gasses and high electric voltage would produce an “invisible light,” or ray, that was capable of passing through human tissue leaving only the bones and metals visible. The news of this scientific discovery spread like wildfire and soon became a medical breakthrough. In fact, by 1896, X-rays were already being utilized clinically in the United States for various medical injuries.

xray w shadow.jpg

X-ray apparatus and induction coils invented by W.C. Roentgen

Read More

Topics: medical devices