• 2020-05-05 06:40:46

MDA has issued a new guidance document on how to bring in special-access devices for specific purposes into Malaysia. MDA defines special access medical device as medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable.

• 2020-05-05 06:26:29

MDA has issued a draft guidance document for getting an exemption for export-only medical devices from registration requirement. This draft is open for public comment and the official document is expected to be released soon.

• 2020-05-05 06:04:25

Regarding the implementation of the Digital Signature system which began on 14 February 2019, the Indonesian Ministry of Health determines the format of Labelling Material Design documents uploaded for product registration .

• 2020-05-05 05:53:22

8 medical devices have been newly notified as “drugs” by government of India. These devices will henceforth be closely regulated and monitored for safety and performance.

• 2019-11-15 03:04:06

In recent years, NMPA has mandated all applicants to manage qualification of their medical device suppliers. However, not all of supplier would like to reveal the confidential information to their customers regardless if they have already disclosed such information at the time of registration.

• 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 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 14:01:43

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.