In our May newsletter, we mentioned that in July, Japan would start allowing online submissions. At that time, online submissions of new drugs, new medical devices, improved medical devices with clinical data, IVDs for new products, and IVDs with clinical data were acceptable. Now, as of... Read More
Cybersecurity risks are now heightened by medical devices which are connected via the Internet and Intranet in hospitals and home networks. The Cybersecurity Agency Scheme for Medical Devices rates each device according to its cybersecurity risk. This scheme includes four designations of... Read More
Technical testing is an integral component of the medical device registration process in China. In October 2022, the China NMPA announced that the new Chinese standard related to the safety of electric medical devices – BG 9706.1-2020 – will come into effect on... Read More
A recent study by a research department at the Japan Pharmaceutical Manufacturer Association (JPMA) outlines how many Japanese and foreign drug companies are not increasing (and in some cases decreasing) their investment and focus in Japan’s drug market. One of the many... 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
In late October, India’s Ministry of Health and Family Welfare has set up a committee to put together an extensive drug database. The committee will initially include 7 people. The goal of the drug database will be to provide an exhaustive record... Read More
Recently, the Korean Ministry of Food and Drug Safety (MFDS) issued new device renewal requirements. For renewals, the medical device in Korea cannot have had any serious adverse events, and there needs to be a production or import track record and documentation.... 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
Over the last few months, Japan has upgraded regulations for labeling for medical devices and pharmaceuticals. In mid-September, Japan promulgated new regulations for regenerative products outlining the labeling requirements on containers for – 1. individual unit packaging, 2. the unit of packaging... Read More