• 2020-02-21 07:00:53

CDSCO has issued a notice recently regarding intended uses of implantable medical devices, as stipulated in the Fifth Schedule (Clause 3.5) of Medical Devices Rules, 2017.

• 2020-02-21 06:59:18

MDA has introduced a revision to the Circular Letter No 1 of Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative. This Ciruclar Letter essentially discusses all the duties and obligations which fall upon local manufacturers and local authorized representatives, after placing devices on the market.

• 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 06:57:58

The Medical Device (Duties and Obligations of Establishments) Regulations 2019 (‘Establishments Regulations’) specifies in detail the responsibilities of establishments involved in the importation, distribution and post-market surveillance of medical devices in Malaysia.

• 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 06:53:42

It is honor for Qualtech to receive an invitation from Hujing College, USST for the program ‘Training and Exchange of Precision Medical Innovation Technologies under the Background of Comprehensive Health’ in Shanghai, China from 25th November to 8th, December 2019. Diversity group of trainees consisted of innovators and professors from Brazil, South Africa, Israel, and Singapore, where Qualtech ASEAN represents Malaysia and Thailand.

• 2020-02-21 06:52:42

Recently on November 13, NMPA had issued a notice on the suspension and rectification of a domestic manufacturing factory,, instructing the manufacturer to stop production until rectification is completed and approved by NMPA. On the other hand, nearly 30 manufacturers (domestic and foreign) initiated voluntary recalls of their products in November. Similar news has been cropping up in recent year, and it’s foreseeable that NMPA will keep strengthening the surveillancein the future.

• 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.