Obtaining approval to sell medical devices in Vietnam just got harder – and more costly – for importers. Starting in January, all medical devices marketed in the country will require approval by Vietnamese authorities. Previously, some devices already approved by the European... Read More
In the wake of the massive recall of a hypertension drug last year, South Korea is stiffening its control of pharmaceutical safety. Beginning immediately, the country’s primary regulatory body, the Ministry of Food and Drug Safety (MFDS), is mandating manufacturers of raw... Read More
Moving to strengthen its regulations of medical devices offered for sale in India, the nation’s medical device regulatory authority announced it will mandate the registration of eight categories of devices that did not previously require such approval. The decision by India’s Central... Read More
Moving to ensure patients can access innovative drugs and medical devices faster, Japan’s Ministry of Health, Labor and Welfare (MHLW) plans to amend the nation’s health and safety laws to speed the development of a fast-track review process. The scope of the... Read More
China’s proposed new Drug Administrative Law (DAL) would significantly strengthen safety requirements for manufacturers of drugs and vaccines, establish a readily accessible repository of drug safety information and increase civil fines for violations. According to a draft of the law, drug manufacturers... Read More
A requirement by the Muslim-majority nation of Indonesia that vaccines, pharmaceuticals, food and cosmetics be certified in compliance with Islamic dietary laws will not go into effect until at least 2024, officials announced in February, 2019. The decision pushes back a previous... Read More
In a sign that China intends to increase its scrutiny of foreign medical device and drug companies, its regulators are instituting a process for inspecting overseas medical manufacturing facilities. The new guidelines announced in late December by China’s National Medical Products Administration... Read More
Patients in South Korea are able for the first time to buy genetic testing kits at stores and on the internet, making possible self-diagnosis of some diseases that until now mandated a hospital visit. The decision by Korean authorities to permit the... Read More
Starting January 1, China began requiring detailed labelling and descriptions in Chinese on most medical device products sold in the country. The new regulations from China’s National Medical Products Administration, the administrative body responsible for the regulation of medical devices and pharmaceuticals... Read More
China’s National Health Commission plans to formulate the country’s first-ever dedicated treatment guidelines for rare disease patients, along with a treatment network and a patient registration system – government authorities announced in January. The announcement by the Chinese government is part of its emerging... Read More