• 2020-02-14 07:43:27

Based on a recently issued circular letter, No. 3 Year 2017 (Rev.1), MDA has reiterated the implementation and enforcement date for the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combinations Products, which will be strictly enforced in Malaysia starting July 1st, 2019.

• 2020-02-14 07:42:08

On 30th of November 2017, following recommendation from the Advisory Board, Thai FDA had announced four new checkpoints which regulate importation and exportation of medical devices. The new checkpoints are located in four different provinces as follows:

• 2020-02-14 07:41:28

The Thai Medical Device Control Division has amended the application form for medical device advertising following the Thai FDA announcement on 19 January 2018. It is appropriate to report complete and clear information to monitor the impact of disclosure.

• 2020-02-14 07:40:37

In light of the new Medical Device Rules 2017, CDSCO/CLA/SLA shall have updated information of laboratories involved in testing of medical device & in vitro diagnostics with respect to their laboratory reports and decision on performance evaluation of products made by stakeholder/regulator.

• 2020-02-14 07:39:04

The Government of India, Ministry of Health and Family Welfare has released guidelines with respect to Grouping of Medical Devices for applicants who intend to apply for a license to import or manufacture medical devices for sale and distribution in India.

• 2020-02-14 07:37:59

CFDA has released the draft of 3D-printed medical device guidance during the last week of February. The draft guidance provides the general requirements of registration rules on 3D printed medical device.

• 2020-02-14 07:35:54

International Medical Device Regulators Forum (IMDRF) held a meeting in China during March 20 to 22. The current chairman, China FDA, proposed two projects and get the support from all IMDRF members.

• 2020-02-14 07:34:46

Medical device regulations in China have changed frequently in the recent years, such as updating of multiple national standard andindustry standards, issuing of product guidance and administrative directives. With its 10-year experience in China's active medical device registration,

• 2020-02-14 07:51:46

The regulatory body for medical devices is Division of Medical Devices and Cosmetics under Taiwan Food and Drug Administration (TFDA). The important legal rules that govern Medical Device Affairs are the Pharmaceutical Affairs Act and the Regulations for Governing the Management of Medical Device.

• 2020-02-14 07:50:05

The applicant may initiate the cancellation of the registration license of imported medical equipment to CFDA. This administrative application will not charge any application fee. The applicant shall prepare the submission documents to cancel the application. The CFDA will conduct a formal review on the cancellation application.