The Medical Device Authority (MDA) made an announcement on Monday aimed at the general public and distributors: informing the public that the purchase of COVID-19 test kits is prohibited; and to inform distributors that COVID test kits must use the special access route for registration and that they are only for distribution specifically to healthcare facilities as selling […]
Last week the Medical Device Authority (MDA) in Malaysia released a new guidance document on face masks and respirators for medical use. The guidance covers performance characteristics, labelling and registration requirements. According to the World Health Organisation (WHO), medical face masks are divided into two categories: procedure masks and surgical masks, both of which are used in clinical/health
Vietnam’s Ministry of Health recently released a guidance document no. 7395/BYT-TB-CT on preparing medical device registrations. The aim of the document is to help applicants better understand and comply with regulations to speed up the appraisal of registration applications and thereby facilitate the circulation of medical equipment on the market. In accordance with the provisions
Vietnam issues guidance document on preparing medical device registrations Read More »
The Philippines Food and Drug Administration (FDA) has resumed access to its online Verification Portal which provides comprehensive lists of FDA Licensed Establishments and Registered Health Products. The portal is open access so that the general public can verify whether a medical device placed in the Filipino market is properly licensed and distributed by an authorized dealer. The portal was
Philippines FDA relaunches verification portal for medical devices Read More »
The Indonesian government has set the stamp duty rate for 2021 at a single tariff of IDR 10,000, which came into force on 1st January. Previously different stamp duties of IDR 3000 and IDR 6000 were applicable; however, a single tariff is now in force to provide equality between paper and electronic documents. This
We’re happy to share that Indonesia’s National Public Procurement Agency (NPPA = LKPP) has again opened its e-Catalogue to imported medical devices. This means that both imported and domestic Medical Devices and Health Service Support Equipment (Non-Medical Devices) can be submitted. The e-Catalogue was last opened to imported medical devices in 2018, however an important difference
Indonesia opens e-Catalogue to imported medical devices Read More »
We’re proud to announce that Mourad Kholti, our CEO and founder, has been appointed the new representative of the Malaysian French Chamber of Commerce (CCIFM – CCI France Malaysia) for the northern region covering Penang, Perlis, Kedah and Perak. Mourad will be a point of contact and support for French business community in Northern Malaysia. Read
Mourad is appointed representative of the Malaysian French Chamber of Commerce Read More »
Catch up on the important regulatory changes that are coming your way in 2021 for medical devices in Southeast Asia in the recording of our live presentation at the Medical Fair Asia, in December 2020. Shouzheng Tan presented a quick fire 20-minute overview of the “Key regulatory changes for 2021 in Southeast Asia that will
Key medical device regulatory changes in Southeast Asia for 2021 Read More »
Asia Pacific’s wound care market is expected to be worth US$3.65 billion by 2025 growing at 10.4% CAGR according to Allied Market Research. This is more than twice the global market growth rate of 4.6% and partly due to changing lifestyles and in particular the increasing prevalence of diabetes – 5 out of the top 10 countries worldwide in terms
Asia Pacific’s wound care market is expected to be worth US$3.65 billion by 2025 Read More »
Updated guidelines on the evaluation of COVID-19 test kits have been released by the Research Institute for Tropical Medicine (RITM) in the Philippines, which cover the “…Evaluation of In Vitro Diagnostic Medical Devices and other related laboratory diagnostic supplies for COVID-19”. These guidelines cover the evaluation of PCR test kits, in vitro reagents, and other
Updated guidelines on Covid-19 test evaluation in the Philippines Read More »
On 20 May 2020, the Medical Device Authority (MDA) in Malaysia, released its first circular letter of the year, stating that there will be a transitional period for the enactment of the Medical Device (Advertising) Regulation 2019. This regulation was due to come into full effect on 1st July 2020. However, due to some implementation
Medical Device Advertising Regulation in Malaysia – transitional period Read More »
The National Telecommunications Commission of the Philippines issues permits and certificates to importers of indoor equipment and devices that require Wireless Data Networks (WDN) or are WIFI-enabled or Bluetooth-enabled medical devices. Background The National Telecommunications Commission (NTC) is responsible for the supervision, adjudication, and control of all telecommunication services in the Philippines. The NTC works closely
NTC permit to import wireless medical devices to the Philippines Read More »
To ensure safety, the Philippines FDA will ban powdered medical gloves and have advised the general public, including all healthcare professionals, that powdered gloves will be phased out by the end of 2018 in favor of powder-free medical gloves. The Philippines Food and Drug Administration (FDA) has released Advisory No. 2017-180, dated June 20, 2017,
All local manufacturers, distributors (importers, exporters and wholesalers), traders and re-packers of medical devices, in-vitro medical devices and health-related devices in the Philippines shall comply with the labeling requirements as drafted by the Center for Device Regulation, Radiation Health and Research (CDRRHR). Republic Act No. 3720 (Food, Drugs and Devices and Cosmetics Act), as amended by RA
Medical device labeling requirements in the Philippines Read More »
