Regulatory Affairs
APAC
Approval of Medical Devices worldwide
Medical devices that are "Made in Germany" are associated with quality, safety and performance. For this reason they are in high demand in the populous countries of the APAC region. But the requirements are very different in each country. Will you be able to find clarification within a large number of regulatory requirements?
APAC - Asia-Pacific Economic Area
The abbreviation APAC stands for the Asia-Pacific Economic Area, which comprises the regions in Asia, Australia and Oceania. These countries in the APAC region are of particular economic interest to manufacturers of Medical Devices: Besides China, the APAC region offers further economically extremely interesting markets:
- Australia
- Japan
- South Korea
- Singapore
- Malaysia
- Taiwan
- India
Below you will find a small selection of the challenges involved in obtaining approval for Medical Devices in some of these countries. Let our Regulatory Affairs experts tell you how you can best deal with these challenges.
Medical Device Regulatory Affairs in Australia
Will a successfully completed MDSAP audit soon become a regulatory requirement in Australia?
The regulatory authorities for Medical Devices in several countries, including the Australian Therapeutic Goods Administration (TGA), have joined forces within the International Medical Device Regulators Forum (IMDRF). They have developed a program to review country-specific QM requirements in a single audit. The MDSAP aims to reduce the manufacturer's workload. The Australian TGA currently still accepts EN ISO 13485 certification for European manufacturers. In Canada, the MDSAP certification has been mandatory for the approval of Medical Devices since 2019. However, our experts expect that Australia will soon follow suit.
Approval of Medical Devices in Japan
Do you know which local obligations you have to fulfill when placing Medical Devices on the Japanese market?
For approval in Japan, a local representative, the Marketing Authorization Holder (MAH), must be selected. The MAH must employ at least three managers who are individually responsible for the quality, safety and monitoring of the Medical Device in Japan and thus fulfill the local obligations. The MAH must be selected thoroughly, as it becomes the owner of the certification and thus also determines, for example, the distribution channels. If you choose a Japanese distributor as MAH, disagreements may arise if you want to expand your distribution structure. Therefore, the Designated Marketing Authorization Holder (DMAH) construct should also be considered.
Approval of Medical Devices in South Korea
For the approval of most Medical Devices in South Korea, an audit by a Korean institution must be carried out in your company. Do you know the additional Korean requirements for your Quality Management System?
The conformity assessment procedure in South Korea is similarly complex as the European one. Especially for active Medical Devices there are high market entry barriers due to high requirements on electrical safety and own conformity mark. For example, it is required that technical tests are performed in Korean test centers and that an on-site GMP audit is conducted. Whereas pest control, that is to be integrated into your QM System, is rather a small hurdle for you and your company.
Approval of Medical Devices in Taiwan
Is your Medical Device suitable and designed to be connected to the Taiwan power supply system?
The power supply is 110 V at 60 Hz frequency in Taiwan and is still influenced by the Japanese colonial period. Verification and validation of your product must also be made for these technical configurations. Besides support at the compliance with formal requirements in the individual countries, a main topic of our work is the creation of Technical Documentation, which can be “reused” for the registration in different countries.
qtec as your partner
In addition to assistance in complying with the formal requirements in the individual countries, the preparation of Technical Documentation that can be "reused" for approval in different countries is a focal point of our work.