Over a 15 year career in the medical device industry, Albert has been responsible for new technology commercialization into Asian markets for large companies such as GE, Medtronic and Philips.
Albert joined Asia Actual to share his knowledge and experience with dynamic clientele covering market assessments, market access, reimbursement, KOL identification and development, trade finance, and regulatory compliance. He brings an infectious positive outlook and impressive seasoned professionalism to projects. Prior to transitioning to medical devices, Albert enjoyed a successful career in the petrochemical industry.
Albert has an undergraduate degree from Diponegoro University in Chemical Engineering and an MBA from the University of Birmingham with specialization in Strategic Management and Finance. A native of Indonesia, Albert has been living in Singapore for over 12 years and speaks fluent Bahasa Indonesia and English. Away from work, Albert is an engaged husband and father, and can often be found on the tennis court.
On November 30th, the Hong Kong Medical Device Division (MDD) issued formal guidance on the requirements to make changes to medical device licenses registered in the Medical Device Administrative Control System (MDACS).
On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect. A translated version of the document is available on Asia Actual’s website here. All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.
China’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.
China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. This brings the total number of clinical trial exempted product categories in China to 1,025.
China is developing new standards and processes for the regulation of advertising for medical devices (as well as pharmaceuticals, food supplements and cosmetics). The goal is to maintain the order of the advertising market, standardize the review of advertisements and protect the rights and interests of consumers.
The Department of Health (DH) in Hong Kong has announced a new strategy for the procurement of medical devices (MDs), effective from June 21, 2023.
In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.
On February 20th, 2023, China’s Center for Medical Device Evaluation (CMDE) issued new guidance extending the response deadline to requests for supplementary documents to 12 months.
In Taiwan, beginning June 1st, 2023, manufacturers of Class II medical devices will need to ensure products placed on the market have compliant Unique Device Identification (UDI) labeling.
On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.
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