JAPAN: Approval Criteria for Dental Implants are Amended - December 2022/January 2023
- 2022-12-27 07:16:43
On November 2nd, Japan's Ministry of Health, Labor and Welfare announced an amendment in the Approval Criteria for dental implants.
了解更多On November 2nd, Japan's Ministry of Health, Labor and Welfare announced an amendment in the Approval Criteria for dental implants.
了解更多According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.
了解更多NMPA has released the latest guidelines, which aim to guide registration applicants in the preparation and writing of passive implantable medical device stability research and registration application materials. While it further also provides a reference for the technical review departments.
了解更多The TGA has recently published a guidance document of an overview for patient information materials. The patient information materials consist of patient information leaflets (PIL) and patient implant cards (PIC), for implantable medical devices and active implantable devices. From December 1st, 2021, all implantable or active implantable devices will require patient implant cards and patient information leaflets, unless they are specifically excluded from these requirements.
了解更多Asia Pacific forms one of the most promising dental device markets in the world. In this edition of QT Analysis, we look into the market size waiting for you to take advantage of and the requirements to register your dental devices in this region.
了解更多The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).
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