• 2020-02-12 15:58:33

For the registration of any medical device with most regulatory authorities around the world, the first step would be to prepare the device’s technical documentation or a dossier. Technical documentation are the documented evidence, normally an output of the quality management system,

• 2020-02-14 04:03:25

海外医機器技術協力会(OMETA), Japan Association of Medical Device Industry (JAMDI), DEKRA Japan, and Qualtech Japan are jointly organising an upcoming seminar in early July (July 6th, 2018) in Japan.

• 2020-02-14 04:02:32

Large medical equipment is a special type of equipment with complex technology, large capital investment and high operational cost, creating a great impact on medical expenses. This April, China government has issued “The New Acceptance Catalogue for Large Medical Equipment”.

• 2020-02-14 03:57:58

CNDA welcomes public comments on the recently drafted policy entitled, "Principles of the Clinical Trial Inspection for Medical Devices", hereby referred to as "Principle".

• 2020-02-14 03:52:53

China National Drug Administration (CNDA) (formerly known as CFDA) has issued a new policy for Hong Kong medical device manufacturers to enter Mainland China market. CNDA can now accept Certificate of Listing and Certificate to CNDA as marketing approval and Quality Management System certificates which are the necessary documents for medical device registration in China.

• 2020-02-13 06:24:58

According to rule 19 of the Medical Device Rules 2017, the central government may establish “Central Medical Devices Testing Laboratories” for the purpose of

• 2020-02-13 06:21:59

Medical devices to be registered in Malaysia must first undergo conformity assessment with a Conformity Assessment Body, to demonstrate its conformity to the requirements of medical device law. In regards to this, currently there are conformity assessment service with good quality and also comparable to global assessments or test carried out by local laboratories.

• 2020-02-13 06:15:29

All concerned Industry/Stakeholders were invited to attend the FDA Executive Presentation on New Fee Structure and Modernization scheduled last June 28-29 which was held at the Philippine International Convention Center, Pasay City. Based on the informal talks between Qualtech and PFDA,

• 2020-02-13 06:13:18

Health Sciences Authority announces changes to the regulatory process for medical devices, including faster market access for lower risk devices, clearer regulatory controls for De novo device and high risk device, strengthen Post-market measures. 

• 2020-02-14 04:21:46

A research conducted by BMI Espicom showed that the scale of the global medical device market is expected to reach US$38.91 billion in 2019, of which Japan has the world’s second largest medical device market, second to United States. Global medical equipment manufacturers in addition to Europe and the United States well-known manufacturers (GE, Medtronic, Johnson & Johnson, etc.),