• 2020-02-12 14:08:37

Medical device regulations in China have changed frequently in the recent years. With its 10-year experience in the registration of non-active medical device in China, Qualtech would like to share an overview of the common roadblocks of the registration process a foreign manufacturer frequently encounters.

• 2020-02-12 14:22:55

At the end of August, the China Market Supervision Administration (the leader institute of NMPA) has officially published the “Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices”.

• 2020-02-12 14:21:58

Last August, NMPA has issued a draft entitled “Measures for the Supervision and Administration of the Local Authorization Agent for Imported Medical Device” in order to ensure the safety and effectiveness thereof. The draft was also aimed at regulating the behavior of local authorized agents of imported medical devices.

• 2020-02-12 14:21:01

In order to reinforce the supervision and management of the development, production, operation and use of medical devices, NMPA (National Medical Product Administration) has issued the “Draft of UDI Rules for Medical Device” at the end of August with the primary objective of establishing a unique identification system (UDI) for medical devices. This regulation applies to medical devices that are sold and used in China.

• 2020-02-12 14:18:59

In carrying out the medical device registration process in Indonesia the applicant must fulfill administrative and technical documents requirements.

• 2020-02-12 15:56:38

The National Medical Product Administration (hereinafter referred to as NMPA) has released a list of medical device industry standards covering the new and amended standards from August 7th. Notable standards included in this exhaustive list, among others, include "Electrical safety standards for medical electrical equipment",

• 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 15:09:17

Nearly eight months after the implementation of the Medical Device Rules 2017, the Indian Pharmacopoeia Commission (IPC) has brought out the first reference document for medical devices manufactured and sold in the country.

• 2020-02-12 15:06:56

MDA has issued a new announcement regarding registration application of medical devices and licensed establishment under Medical Devices Act 2012 (Act 737) which are still pending, following the end of transition period.

• 2020-02-12 15:05:51

In July 2018, Medical Device Authority (MDA) had issued Circular Letter No.4 Year 2018. This was pertaining medical devices manufactured or imported into Malaysia for eventual exportation purposes only. According to Section 5(1) of Medical Devices Act 2012 (Act 737),