On February 14, the Taiwan FDA (TFDA) promulgated new regulations for Class 2 and Class 3 medical devices. For these devices, a UDI code needs to be stamped on the outer frame of every packed medical device. For very small devices, the... Read More
On November 4, the NMPA released a draft regulation entitled “Announcement on the Administration of Chemical API Registration Renewal” and is seeking public comments by December 3. The announcement and regulation is expected to go into effect in one year. Before the... Read More
In November 2018, Malaysia’s Medical Device Authority (MDA) issued the third edition of their Change Notification for Registered Medical Devices. On November 2 this year, the MDA updated this notification. The new updated version includes two main new sections – Clause 5.8... Read More
Recently, the Korean Ministry of Food and Drug Safety (MFDS) issued new device renewal requirements. For renewals, the device in Korea cannot have had any serious adverse events, and there needs to be a production or import track record and documentation. Required... Read More
According to the new Administrative Measures for Drug Recalls issued on October 26, 2022, Marketing Authorization Holders (MAHs) of drug products are responsible for drug recalls, not drug manufacturers. More specifically, hospitals, drug makers, and drug suppliers are only responsible for helping... Read More
China’s State Administration for Market Regulation announced on September 1 new regulations of online drug sales. The regulation will be implemented on December 1 to strengthen and increase oversight. The Measures for the Supervision and Administration of Online Drug Sales includes 6... Read More
On May 18, the Ministry of Health and Family Welfare announced a new Rule 43A, which outlines the conditions in which an approved device license can be canceled or suspended. Per this new rule, if a device license does not comply with... Read More
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) announced that it will implement a new good pharmacovigilance (GVP) inspection program at the beginning of 2023 with a voluntary phase. These inspections ensure that manufacturers of pharmaceutical products and their affiliates conform to the... Read More
For the first time, regulators in Japan are carrying out surprise inspections at facilities where pharmaceutical and medical device products are manufactured. The inspections, which began in August, are designed to improve Japan’s system for ensuring the products are consistently produced according... Read More
Eight months after Singapore first announced its plans to establish a Unique Device Identification (UDI) system for medical devices, the country’s health regulatory authority has released draft guidance on how the system will work. According to the guidance, when the system is... Read More