Korean regulatory authorities have recently begun a pilot program that will simplify the medical device registration process. Under this new program, medical device companies whose products meet the pilot program conditions can submit a single application to the Korean Ministry of Food... Read More
In late 2015, the Medical Device Branch (MDB) of Singapore’s Health Sciences Authority (HSA) released updated guidance documents on the Change Notification System for Registered Medical Devices. The updates to the guidance documents are intended to make the notification process more efficient... Read More
Unlike the other Asian countries, in Indonesia, an independent, third party entity in-country cannot register foreign devices. According to Indonesian law, devices can be registered via the foreign company’s Indonesian distributor or the foreign company’s subsidiary operation in Indonesia. To get around... Read More
Currently, medical devices do not require registration in Hong Kong. Some foreign device companies have registered their devices via a voluntary system to date. Recently, Dr. Ko Wing-man, Hong Kong’s Secretary of Food and Health, said that the government will soon finish... Read More
Before the implementation of Japan’s Pharmaceutical and Medical Device Act (PMD Act) in November 2014, software and hardware were regulated as one single unit, and there was no path to registering software independent of a device. Although the PMD Act has been... Read More
In November 2015, key representatives of the U.S. and Chinese governments met to address bilateral trade issues. Officials discussed a number of important issues that affect the registration of medical products in China. According to the U.S. factsheet on the joint commission, U.S.... Read More
Beginning November 20, 2015, all medical devices that are imported into Vietnam are subject to a new set of regulations laid out in Circular 30. This new circular supersedes the previous regulations found in Circular 24 dated June 21, 2011. However, all... Read More
On May 19, 2015, the China Food and Drug Administration (CFDA) posted details of the requirements for Clinical Evaluation Reports (CERS). The guidance is applicable for the evaluation of Class II and III devices for registration in China. The key issue is... Read More
In July, India’s Ministry of Health and Family Welfare formally launched the Materiovigilance Program of India (MvPI). This plan will monitor the quality of medical devices in India and seek to improve patient health and safety. According to the Indian Pharmacopoeia Commission,... Read More
Although the final text of the Trans-Pacific Partnership (TPP) deal has not yet been released, media sources have been speculating about important provisions regarding biologics and medical devices. Fortune magazine has reported that the signatory countries will be able to sign up... Read More