on

DRAFT FOR COMMENTS: ABRIDGED PROCESSING OF APPLICATION FOR MEDICAL DEVICES

Leave a Comment / Philippines, Regulatory updates / By Andaman

The Philippines Food and Drug Administration (FDA) seeks comments from the Medical Device Industry regarding new draft guidelines that could provide faster registration processing and approval should the medical device qualify for the abridged route. Advisory 2021-3084 was issued last November 18, 2021: Abridged Processing of Application for registration/notification of medical devices approved by the […]

DRAFT FOR COMMENTS: ABRIDGED PROCESSING OF APPLICATION FOR MEDICAL DEVICES Read More »

MDA is Aware of Buyer Concerns About Collecting and Storing Their Personal Information When Purchasing Self-Test Covid-19 Kits in Malaysia

Leave a Comment / Malaysia, Regulatory updates / By Andaman

The purchase of self-test kits for COVID-19 requires providing personal information at sales premises authorized by MDA and KPDNHEP, and the collection of this information is a growing concern among buyers. MDA is aware of the concerns among users and would like to clarify that the requirement to record this personal information is imposed on

MDA is Aware of Buyer Concerns About Collecting and Storing Their Personal Information When Purchasing Self-Test Covid-19 Kits in Malaysia Read More »

Update to Guidance on Special Access Routes (SAR) Takes Effect 1 April, 2022

Leave a Comment / Regulatory updates, Singapore / By Andaman

Singapore’s Health Sciences Authority published new updates to the guidance document titled ‘Guidance on Special Access Route (SAR) Rev 2’. The announcement is part of HSA’s effort to strengthen regulatory oversight on the importation and local use of unregistered high-risk medical devices requested by qualified practitioners or public healthcare facilities. This guidance document takes effect

Update to Guidance on Special Access Routes (SAR) Takes Effect 1 April, 2022 Read More »

Indonesia VAT to rise 1 April, 2022

Leave a Comment / Indonesia, Market access updates / By Andaman

Indonesia’s Minister of Finance, Sri Mulyani, set the VAT rate to increase from 10 percent to 11 percent, effective 1 April 2022. Basic goods and services (rice, meat, public transport, etc.) will continue to be exempted. All transactions apart from basic goods and services as mentioned above will rise to 11% including VAT import and

Indonesia VAT to rise 1 April, 2022 Read More »

The World Health Organization (WHO) Awarded Singapore the highest recognition for an advanced Medicine Regulatory System

Leave a Comment / Regulatory updates, Singapore / By Andaman

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

The World Health Organization (WHO) Awarded Singapore the highest recognition for an advanced Medicine Regulatory System Read More »

Medical Device Authority releases draft amendment or second edition of Medical Device Guidance for PPEs

Leave a Comment / Malaysia, Regulatory updates / By Andaman

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

Medical Device Authority releases draft amendment or second edition of Medical Device Guidance for PPEs Read More »

The Thailand FDA has terminated its pre-submission system as of March 15, 2022

Leave a Comment / Regulatory updates, Thailand / By Andaman

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 »

Draft FDA Circular for comments amending FDA Circular 2021-002-A

Leave a Comment / Philippines, Regulatory updates / By Andaman

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 »

Andaman Medical receives ISO 13485:2016 Certification

Leave a Comment / Events & Other News / By Andaman

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 »