• 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.

• 2019-12-18 09:11:40

Registration form regarding the Competency Development for Medical Device Manufacturing in accordance with Announcement will be hosted by Medical Device Control Division, Food and Drug Administrative.

• 2020-07-31 10:02:04

Products Containing Alcohol for Humans, Animals Sterilization and Medical Device have now joined the family of Notified Medical and will be implemented in March 2019.

• 2020-07-31 10:08:37

ThaiFDA sturdily believes that via the implementation of Good Distribution Practice for Medical Devices, manufacturers, importers and distributors must comply to ensure quality, safety and performance throughout the supply chain.

• 2020-05-06 09:31:48

PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.

• 2020-07-31 10:30:12

The Act aims to specify Medical Device Control in accordance with the ASEAN Agreement on Provisions Medical instruments. As well as refresh the Act to suit the transformation of medical device industry, where all citizen can embrace standardized and qualified medical device.

• 2020-05-06 09:11:58

MOH established a Medical Device Risk Classification System on the MOH website called SIKLARA. This system aims to facilitate applicants in classifying medical devices and minimalize errors in class determination. However, this system is only available in Indonesian.

• 2020-05-06 08:22:59

The NMPA has issued the first global regulatory on the lifetime of active medical devices. This guideline provides various aspects on lifetime evaluation, and all manufacturers producing active medical device should carefully regards this specific issue.