Singapore is the first WHO member state to achieve the status of Maturity Level (ML) 4, the highest level of attainment for a regulatory system classification, for its advanced medicines regulatory system. The Health Sciences Authority (HSA) is the first National Regulatory Authority (NRA). International assessors and WHO officials reviewed HSA Singapore in 2021 and […]
Malaysia’s Ministry of Health’s Medical Device Authority (MDA) released a draft amendment or second edition of Medical Device Guidance (MDG) for Personal Protective Equipment (PPE) requirements. The amendment is to the September 2021 first addition MDA/GD/00558. The draft document provides guidance to healthcare facilities and establishments. Specifically, those that deal with requirements for PPE that
The announcement was made on March 7, 2022, by the Medical Device Control Division of the Food and Drug Administration Ministry of Public Health (MOPH) of Thailand. Submit an application through E-submission if you are a medical device registrant wishing to check the risk classification and grouping. Expect to pay an application fee of 500
The Thailand FDA has terminated its pre-submission system as of March 15, 2022 Read More »
The Philippines FDA issued an amendment to Circular no. 2021-002-A entitled “Addendum to FDA Circular No. Circular no. 2021-002 Re: Full implementation of administrative order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a medical device based on the ASEAN Harmonized Technical Requirements. The Circular for comments amending FDA Circular 2021-002-A shall take effect
Draft FDA Circular for comments amending FDA Circular 2021-002-A Read More »
We are very happy to announce that we have received ISO 13485:2016 certification. This certification is a landmark in assuring clients receive the best quality and service from Andaman Medical and is the result of implementing a vigorous quality management system that governs their consulting services. “I am extremely proud of the dedication of our
Andaman Medical receives ISO 13485:2016 Certification Read More »
The Malaysian Medical Device Authority (MDA) has released guidance on the requirements for registering Refurbished Medical Devices (MD/GD/0060). The guidance document provides information on how to register a refurbished medical device before it can be placed in the Malaysian market. What is a refurbished medical device? According to the ASEAN Medical Device Directive (AMDD), it
Malaysia releases new guidance on registration of refurbished medical devices Read More »
Malaysia’s Medical Device Authority (MDA) has released draft guidance for the classification of rehabilitation, physiotherapy and speech therapy devices. Industry stakeholders are invited to comment on the draft guidelines until 2 March 2022. The guidance states that the classification as a medical device will be made upon the clear indication of the mode of action
Malaysia’s Medical Device Authority (MDA) has released draft guidance on medical device grouping classification rules. The draft guidelines are open for comment by stakeholders until 28 February 2022. The purpose of the document is to provide guidance on determining the appropriate grouping for medical devices during the medical device registration application. This draft guidance applies
Malaysia MDA releases draft guidance on medical device grouping classification rules Read More »
Indonesia’s Ministry of Health has launched a dedicated e-Catalogue for medical devices on Friday 11 February 2022. Previously, one e-Catalogue existed for all products procured by the government from street lighting to pacemakers. This has now been split into a national e-Catalogue for items that are required nationally, and sectoral e-Catalogues which are specific to
Indonesia’s Ministry of Health launches dedicated e-Catalogue for medical devices Read More »
The Philippines Department of Health has issued an update to information concerning the Price Limit for Covid-19 RT-PCR Testing. The initial Circular No. 2021-0374 was issued on 26 August 2021. This amendment (Circular No. 2021-0374A) clarifies the price limit and other matters as follows: Turnaround Time for RT-PCR Tests. Laboratories are mandated to observe a
Philippines: Price Limit for Covid-19 RT-PCR Testing Read More »
The Philippines Food and Drug Administration (FDA) is seeking comments from IVD manufacturers and distributors (importers/exporters/wholesalers) on draft guidelines entitled “Specific list of registrable IVD medical devices and revised technical requirements for registration of COVID-19 test kits”. The draft FDA Circular provides a specific list of registrable IVDs including the addition of COVID-19 test kits.
Philippines FDA: List of registrable IVDs – draft guidelines for comments Read More »
Indonesia’s Ministry of Health has announced that it has simplified registration for some Class A medical devices and Classes 1 & 2 of household health supplies (PKRT). Medical Device Distribution Certificate (IDAK, previously called SDAK) holders can take advantage of this new simplified registration by applying for a Distribution Permit Notification (Izin Edar Notifikasi Alkes
Indonesia introduces simplified registration for some class A medical devices Read More »
The Malaysian Medical Device Authority (MDA) has launched an enhanced version of MeDC@St, its online application system for medical device registrations, at the end of January 2022. MeDC@St 2.0+ will incorporate additional features such as changes to certain modules including: Change Notification module Change notification applications are now allowed to combine Category 2 and Category
The Philippines Department of Health (DOH) has released guidelines on the appropriate procurement, distribution and use of antigen self-test kit on 26 January 2022. The guidelines include instructions to manufacturers, suppliers and distributors on ensuring that the instructions for use are user-friendly including a requirement to create a step-by-step video guide and provide translations. All
The Singapore Health Sciences Authority (HSA) has updated regulatory Guidance GN-15 on Medical Device Product Registration to expand the types of approvals from the following reference regulatory agencies: For Class B Medical Devices, the updated reference agencies’ approval types include: The US Food and Drug Administration (US FDA) De Novo European Union Notified Bodies (EU
HSA issues updated guidance on Medical Device Product Registration (GN-15) Read More »
The Singapore Health Sciences Authority (HSA) has issued updated Guidance on the Grouping of Medical Devices for Registration (GN12-2 revision 2). This concerns: Dental Medical Devices of Class B only which wish to apply for registration using dental grouping terms. Applicants may group their dental devices using GN-12-1 or this latest version of the
HSA issues updated guidance on Grouping of Medical Devices for Registration Read More »
The Malaysian Medical Device Authority (MDA) released a new Guideline for the Registration of COVID-19 IVD Test Kits (MD/GL/07) on 24 January 2022. The guideline covers both the registration of COVID-19 test kits for those kits which have previously obtained Special Access Notification or Conditional Approval. It also covers registration for new COVID-19 test kits
MDA Guideline on Registration of COVID-19 Test Kits Read More »
The Malaysian Medical Devices Authority (MDA) has decided that all COVID-19 test kits whether for professional use or for personal use must be registered under Section 5 of the Medical Devices Act 2012 (Act 737) before being placed on the market. This is effective as of 1 February 2022. This means that as from 31
Malaysian MDA announces end of Special Access Route for COVID-19 Test Kits Read More »
The Food and Drug Administration Policy and Planning Service (FDA PPS) of the Philippines has issued draft guidelines for comments and input from industry stakeholders covering the categorization of borderline health products under the jurisdiction of the FDA. The FDA’s jurisdiction covers multiple product categories such as devices, cosmetics, drugs, food, and others. Some health
FDA Philippines issues draft guideline on categorization of borderline health products Read More »
The Food and Drug Administration (FDA) of the Philippines has issued a draft regulation on IVD market authorizations. The draft is open for comments from industry stakeholders until 7 February 2022. Here are the main points of the draft regulation issued by the FDA: New registration, notification and listing certificates specially for In-Vitro Diagnostics will
FDA Philippines issues draft regulation on IVD market authorizations Read More »
The Philippines FDA now accepts applications for registration for COVID 19 Self-Test Kits. The Philippines FDA issued Advisory No. 2021-3604 on 29 December 2021 regarding the start of acceptance of submissions for Special Certification of COVID-19 self-test kits that will be effective as of 6 January 2022, in accordance with the following Memorandums: FDA Memorandum No.
Philippines FDA opens registration to COVID19 Self-Test Kits Read More »
Restrictions for the selling of optical devices and contact lenses online in Malaysia were announced by the Medical Device Authority (MDA) on 7 January 2022. This announcement prohibits the online sale of optical devices or contact lenses on any e-marketing platform except for websites (managed by Registered Optometry Practitioners) that must meet strict guidelines issued
Restrictions for the selling of Optical Devices and Contact Lenses online in Malaysia Read More »
The Food and Drug Administration (FDA) of the Philippines has issued an amendment to FDA Circular No. 2021-023 extending the current validity of market authorizations, Special Certification, for COVID-19 Test Kits, from 31 December 2021 to 31 January 2022. This extension is valid ONLY for COVID-19 Test Kits whose marketing authorization holder applied for re-issuance
COVID-19 Test Kit in the Philippines: ‘authorization validity’ extension Read More »
On 22 December 2021, the Health Sciences Authority (HSA) of Singapore published a medical device advisory alerting all industry stakeholders about a recent suite of cybersecurity vulnerabilities known as the Apache Log4j Vulnerabilities, that could potentially affect medical devices utilizing the Apache Java Logging Library Log4j. These cybersecurity vulnerabilities allow remote code execution by attackers
Medical Device cyber security vulnerability: Apache-Log4j Read More »
The Philippines FDA issued Circular no. 2021-025 listing the latest guidelines for the application of FDA authorizations in light of the extended state of public health emergency. The extended state of emergency came into effect on 13 September 2021 by Proclamation no. 1218 and will last until 12 September 2022 unless lifted earlier or extended
Philippines FDA medical device authorizations during state of emergency Read More »
With the end of the year fast approaching, I would like to take this opportunity to express my best wishes to you for the holiday season. As we all know, 2021 has been another challenging year, with variants surfacing, and countries all around the world experiencing some form of lockdown affecting supply, including in Southeast
On 9 December 2021, the Vietnam government released Decree No. 111/2021/ND-CP which amended Decree No. 43/2017/NĐ-CP on product labeling regulation, including medical devices. This decree will come into effect on 15 February 2022. According to this new decree, organizations and individuals producing, exporting, and importing goods must determine and label the origin of goods, as
Vietnam issues new regulation for product labeling Read More »
The medical device online registration system in Indonesia, Kemkes, will be shut down temporarily, as of 20 December 2021 to 14 January 2022 for maintenance purposes. This was announced on 1 December 2021 by the Ministry of Health in letter No. UM.01.05/5/2046/2021. This means that the online registration system (http://regalkes.kemkes.go.id) will be closed for the
Indonesia Medical Device Online Registrations to Close Temporarily Read More »
New guidance on classifying products as medical devices has been issued by the Health Sciences Authority (HSA), Singapore. The publication of the final document entitled “Medical Devices Product Classification Guide” at the end of November 2021 follows a stakeholder consultation earlier in the year and incorporates additional clarifications on product types as per the feedback
Medical Device Product Classification Guidance for Singapore Read More »
A regulatory fee increase for medical devices in Singapore has been announced by the Health Sciences Authority (HSA). The fee increases apply to various health product categories, retail pharmacies licensing, and permit issuances. The announcement was made on 1 December 2021; the average increment of 3% will take effect on 1 July 2022. The affected
Regulatory Fee Increase for Medical Devices in Singapore Read More »
