• 2020-02-12 14:16:42

• 2020-02-12 15:57:24

It is divided into 12 distinct parts, wherein the 3rd to 11th parts include technical documentations with the following main sections (a) the safety& effectiveness checklist (b) summary of the device (c) research study (d) manufacturing process, (e) clinical evaluation study (f) risk management report (g) technical requirements (h) test reports, and (i) IFU and labels.

• 2020-02-12 15:54:36

In carrying out the medical device registration process in Indonesia the applicant must fulfill administrative and technical documents requirements. Indonesia MOH had a seminar to describe how to prepare the submission document. Qualtech summarizes as this article.

• 2020-02-12 15:02:33

Aligned with these improvements is the development of a module on FDA Payment Portal that caters for all RRD clients of the Center for Device Regulation, Radiation Health and Research (CDRRHR). All manually assessed Orders of Payment (OP) are now integrated into this new payment collection system.

• 2020-02-13 06:04:14

In connection with the stipulation of Government Regulation No. 24 of 2018 on Electronic Integrated Licensing Service or commonly named as OSS (Online Single Submission), the Ministry of Health of R.O.Indonesia stipulates Republic of Indonesia Ministry Regulation number 26 of 2018,

• 2020-02-13 06:02:57

It has been earlier established that Medical Device Authority (MDA) and National Pharmaceutical Regulatory Agency (NPRA) of Malaysia will start to regulate drug-medical device and medical device-drug combination products together, starting July 1st, 2019.

• 2020-02-13 05:54:53

With an aim to strictly adhere to the provisions set by the ASEAN Agreement on Medical Device Directive (AMDD), the PFDA has issued a 3rd draft on the Rules and Regulations for the Registration Application for In-Vitro Diagnostic (IVD) Medical Devices to be placed in the Philippine Market.

• 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,

• 2020-02-12 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.