• 2020-02-21 07:10:23

On December 25, 2019, the NMPA issued the so-called "Guideline for General Naming Rules for Medical Devices" (hereafter simply referred to as the “Guideline”), which is based on the "Medical Device Common Name Naming Rules". The Guideline is formally implemented from now on, and is applicable to medical devices only, not including IVDs.

• 2020-02-21 07:09:30

The Taiwan Council passed the draft of the " Regulations of Medical Devices" (hereafter simply referred to as the “Regulation”) in December 2019. The regulation has medical devices to be legislated independently and thus no longer fall under the Pharmaceutical Affairs Act.

• 2020-02-21 07:06:15

“Essential Regulatory Requirements for Medical Device Approval” Seminar by The Medical Products Consortium of Thailand: MPCT on 27-28 February 2020 is being hosted for the first time in Thailand aiming to promote research develop medical device innovation through the certification assessment process of The Food and Drug Administration Medicine accordingly to international guidelines.

• 2020-02-21 07:04:40

Thai FDA clarifies 3 types of classification of non-in vitro medical device, Licensed medical device, Notified medical device, and General medical device regarding risk assessment. And for In-vitro medical device, the product is classified from class 1 to class 4.

• 2020-02-21 06:58:33

Recently, on 15th November 2019, the Malaysian Government passed the order to gazette Medical Device (Advertising) Regulations 2019 (‘Advertising Regulations’), based on the Medical Devices Act 2012.

• 2020-02-21 06:56:50

Registration form regarding the Competency Development for Medical Device Manufacturing in accordance with Announcement on the Final Draft on Good Distribution Practice for Medical Devices 2020 will be hosted by Medical Device Control Division, Food and Drug Administrative.

• 2020-02-21 06:56:04

In Indonesia, E-Katalog become the most popular platform for the public hospital or government related institution to find required medical device equipment. In October, Government invite Medical Device Company to submit an offering of Medical Devices and Household Health Supplies products to be included in E-Katalog.

• 2020-02-21 06:54:34

Changing some information after device approved can be done through amendment which has shorter timeline for approval. However, not all of the changes in the device can apply for amendment. Indonesia Ministry of Health elaborate specific criteria for the type of changes that can be reported as amendment to MoH.

• 2020-02-21 06:51:47

On September 17th, IMDRF, the International Medical Device Regulators Forum, has passed the proposal of Medical Device Clinical Evaluation, with unanimous approval of the IMDRF members. This proposal is written by Medical Device Clinical Evaluation Working Group, which is led by China NMPA.

• 2020-02-21 06:49:55

In the past weeks, Qualtech has participated in the following three events: MEDICA in Germany, the Design of Medical Device Conference in Shanghai and the OMETA Seminar in Osaka.