• 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.

• 2022-07-26 11:26:52

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.

• 2022-04-27 11:06:03

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.

• 2021-09-29 00:29:09

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.

• 2021-04-26 03:19:54

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.

• 2020-11-27 01:49:09

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).

• 2020-10-28 02:13:28

It is our great honor to invite Dr. Wei-Jen Chang, a professor from the school of Dentistry at Taipei Medical University, to speak at the Digital Dental Implant Workshop, which will be held from 2020/11/11 (Wed) to 2020/11/12 (Thu) 09:00-17:30 (GMT+8).

• 2020-06-16 03:53:06

Thailand Ministry of Public Health’s 2019 Announcement regarding Silicone Breast Implants will be implemented from June 15th, 2020 onwards.

• 2020-05-12 07:03:38

We discuss the different types of cosmetic implants and the key drivers to their ever-increasing market growth. We focused on the fastest growing market share, ASEAN, and the top players in the different types of implants.

• 2020-02-21 06:46:06

IMPLANTED SILICONE BREAST PROTHESIS 2019