• 2019-11-15 03:03:19

In order to strengthen the quality control of software medical device products, the State Drug Administration has prepared the "Appendix Independent Software for Medical Device Manufacturing Quality Control Specifications (Draft for Comment)" and solicited public opinions.

• 2020-02-12 09:09:07

On December 31, 2018, the Vietnam Ministry of Health (MOH) issued Decree No. 169/2018/ND-CP amending and supplementing some articles of Decree No.36 on Medical Device Management and took effect from the date of signing.

• 2020-02-12 14:07:31

In November, MDA had issued three major guidance documents, two of them being revised editions. One of these two is the 3rd revised edition of Guidance Document for Change Notification for Registered Medical Device in Malaysia.

• 2020-02-12 14:04:30

MDA has recently released a new guidance document regarding the requirements for application of Certificate of Free Sale (CFS) for export only medical devices. There had been plenty of queries received by MDA on the application of CFS for various applications and as a first step, they have released this GD, specifically for export only medical devices.

• 2020-02-12 14:03:26

Starting January 2019, Medical Device Marketing Authorization License will be issued in electronic form. This is in accordance to PMK No. 62 year of 2017 Article 22, which stated that Marketing Authorization License will not require stamp and wet signature anymore.

• 2020-02-12 14:01:43

In early November, CMDE has published a draft guideline for the reprocessing validation and labeling for reusable medical devices: Part 1 (hereinafter referred to as the "Guidelines") which solicited opinions from the public.

• 2020-02-12 14:00:16

In early November, NMPA has issued a draft of the guideline entitled, “Biological Evaluation for Medical Device Part 1: General Principles (hereinafter referred to as “the Guideline”) and has sought comments from stakeholders.

• 2020-02-12 13:57:05

Obtaining market access in the Japanese medical device market may sometimes represent a bit of a challenge for foreign manufacturers, we can provide interested customers with the full spectrum of services required for a smooth access to the Japanese market.

• 2020-02-12 13:54:20

On December 7th 2018, TFDA has formally announced that Japanese manufacturers may take a QSD simplified route of application.

• 2020-02-12 14:15:38

Based on the provisions stated in Republic of Indonesia Minister of Health Regulation no. 62 year 2017 and the socialization of procedures for classification of Medical Devices and PKRT, MoH announced the enactment of class determination and the making of billing codes independently by the applicant.