• 2021-09-28 23:56:41

This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.

• 2021-09-29 02:05:59

Starting July 1, 2022, MDA will start to fully enforce the Medical Device (Duties and Obligations) Regulations 2019 or better known as 2019 Regulations. The regulations focus on various medical device-related establishments’ responsibilities on post-market activities.

• 2021-08-26 12:49:31

Thai FDA alerted Medical Device Establishment concerning labeling and device document implementation applicable for all 4 classifications; Licensed Medical Device (Class 4), Notified Medical Device (Class 3+2), and Listing (Class 1). This remarkable movement is aiming to ensure consumer safety while practicing device traceability during post-market surveillance.

• 2021-08-02 06:36:08

On June 30th, Qualtech and ISS AG jointly hosted an online event informing far more than 100 different medical device manufacturers from all around the globe about China’s New Regulations. Qualtech’s team thereby detailed the important updates that the new RSAMD will bring, including the new obligations for product registrants under the nationwide adopted MAH system.

• 2021-08-02 06:26:52

On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.

• 2021-08-01 15:22:19

The PRC State Council has issued the new regulation of Supervision and Administration of Medical Devices—or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021, creating new market access opportunities for global medical device and IVD manufacturers.

• 2021-08-01 15:11:37

Recently, NMPA issued has issued a draft Regulation on self-testing for medical device registration. It has been published for public comments.

• 2021-06-29 11:23:58

On April 16th, Qualtech organized a webinar and guided participants through the Latest updates for medical device regulations in the Philippines, Thailand, and Malaysia. Our experts covered all the major topics and suggested details to pay attention to.

• 2021-06-25 13:10:29

China's Regulations on the Supervision and Administration of Medical Devices have undergone a series of changes recently. In this article, let's take a look at these changes and how you can prepare to implement them in your medical devices in the China market.

• 2021-06-25 12:07:40

The European Medical Device Regulations has been fully enforced starting 26th May 2021, after many delays following the COVID-19 pandemic. It brings forward a set of new standards and requirements which products must comply with, to ensure a high level of public health and patient safety.