In order to distribute medical devices in Japan, compliance with the requirements of the Pharmaceutical and Medical Devices Act is essential.
Certification by a registered certification body is required for designated highly controlled medical devices, designated controlled medical devices, and designated in vitro diagnostic drugs.
As a registered certification body under the Pharmaceutical Machinery Act, SGS conducts certification examinations for designated highly controlled medical devices, designated controlled medical devices, and designated in vitro diagnostic drugs. When conducting QMS surveys overseas, as a general rule, auditors are dispatched from the nearest SGS office to which qualified auditors belong.
For designated highly controlled medical devices, designated controlled medical devices, and designated controlled in vitro diagnostic drugs under the Pharmaceutical and Medical Devices Act, a registered certification body will be the investigation conductor. The audit consists of a certification application audit (product certification audit) and a QMS survey. Even if medical devices have already been approved and certified in other countries, medical devices distributed in Japan must comply with the requirements of the Pharmaceutical and Medical Devices Act. Applications from manufacturers and distributors will be reviewed by the investigator. If you believe that the item is certified, please contact SGS as soon as possible. We will calculate the applicable number of inspection days and issue a quotation. If you have any concerns regarding the application, please contact us.
In addition, based on the QMS Survey Guidelines Notice, SGS' ISO13485 certification can be treated as the basis for making a QMS survey a written survey. If your organization is considering ISO13485 certification, please contact SGS as well.
SGS's certification audit based on the Pharmaceutical Devices Act can support your company's entry into the Japanese medical device market.