• 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.

• 2020-02-12 14:15:38

Based on the provisions stated in Republic of Indonesia Minister of Health Regulation no. 62 year 2017 and the socialization of procedures for classification of Medical Devices and PKRT, MoH announced the enactment of class determination and the making of billing codes independently by the applicant.

• 2020-02-12 14:12:33

MDCO has created and developed a Web-based In Vitro Diagnostic Medical Device Classification Program, where previously only the classification program for General Medical Device was available. This is to facilitate the classification of the In Vitro Diagnostic Medical Device according to its risk level under the Medical Device Administrative Control System.

• 2020-02-12 14:11:38

In order to encourage the development of medical devices intended for rare diseases, CNMPA has drafted a guideline whose key principles where founded on the “Opinions on Deepening the Reform of Examination and Approval System Reform and Encouraging Innovation of Pharmaceutical Medical Devices”  published by the General Office of the State Council.

• 2020-02-12 14:09:42

China National Medical Product Administration (NMPA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. This revision will be effective on December 1, 2018.

• 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.