• 2020-02-13 06:14:29

Following the Executive Presentation on the New Fee Structure and Modernization Initiatives held last June 28-29, a draft of the New Schedule of fees has been posted which aims to notify all stakeholders concerning the significant increase in charges associated with medical registration,

• 2020-02-13 06:11:12

In order for clients to understand the key factors affecting the registration situation of medical devices in China in the last three years (2015-2017), Qualtech has provided an overview and analysis of the medical device registration data (as provided in the following sections of this article),

• 2020-02-14 04:18:38

At the end of May, the China National Drug Administration (CNDA) has issued the "Technical Guidance for Electronic Submission of Medical Device Registration (Trial) (Draft) " (hereinafter referred to as the "Guidance") and sought for public opinion.

• 2020-02-14 04:04:20

Administrative Order 2018-117, otherwise known as the “Effectivity of the New Schedule of Fees” was released in the 2nd of April, 2018 to inform all the FDA Stakeholders and the General Public that a new schedule of fees shall be implemented on the 30th of June 2018.

• 2020-02-14 07:32:41

The Council decides to suspend the implementation of Clause 11 of the Medical Device Registration and Management in the Hainan tourism area. In order to support this suspension, CNDA has released a temporary Order, entitled “The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. The scope of this Order includes all medical devices that are urgently needed for clinical purposes, operation conditions, and a

• 2020-02-14 07:45:46

The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.

• 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 07:34:46

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 07:50:05

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.

• 2020-02-14 07:47:54

The Guidelines released by the Department of Health concerning Medical Device Registration is in place to be officiated following its publication. This shall be implemented a year after its effective date. Delayed implementation allows sufficient preparation for applicants in securing technical documents crucial to the registration process.