In an effort to improve the quality of medical devices distributed in Indonesia, the Indonesian MOH has put in place stricter guidelines. According to the new Circular Letter 03, starting on July 1, 2024, it will now be required that Indonesian medical... Read More
In late July, Indonesia’s government announced GR 28 which is similar to the Indonesian Health Omnibus Law, but with more detailed explanations. This new regulation covers a number of topics. First, it states that the National Health Information System can use data... Read More
In late March, the Philippines FDA (PFDA) has extended the registration date for Class B,C and D medical device registration for devices that were not already on the registrable medical device list. Now, these medical devices do not need to be registered until... Read More
In Indonesia, the Goods and Services Procurement Policy Agency, is responsible for an e-Catalogue that allows the government to purchase a variety of needed products. This is an online Indonesia government language procurement platform. The e-Catalogue in Indonesia was initially set up... Read More
Over the last 20 years, China’s drug business has seen tremendous growth. Western drug companies have heavily relied on China for drug products, drug substances, R&D, clinical trials, etc. However, now with increased geo-political friction between the US and China, more Western... Read More
1. Overview The Ministry of Health, also referred to as Departemen Kesehatan, is the governmental entity responsible for executing health policies. It is headed by the Minister of Health, who reports directly to the Indonesian President. The National Agency of Drug and... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
With over 275 million people, Indonesia is the world’s 4th largest country. Healthcare spending is expected to rise from about $35 per person in 2005 to over $270 per person by 2027. On July 11, the Indonesian House of Representatives announced a... Read More
Recently, the President of Indonesia announced presidential regulation #6 requiring all drugs, biologics, and medical devices to meet Halal law. This law came into effect in mid-January. Medical products that do not have non-Halal components/materials and are made via a Halal manufacturing... Read More