The ASEAN Medical Device Directive (AMDD) was signed by the ten (10) Member States in 2015, with the main objective of harmonizing the medical device regulations and common technical documents which may help medical manufacturers easily penetrate the ASEAN Medical Device Market.
More edtec Japan, Asia’s largest tradeshow dedicated to the design and manufacturing of medical devices will take place from 18 to 20 in April 2018 at Tokyo Big Sight. Qualtech, as a professional medical device regulatory consulting firm in Asia, will participate the event this year to provide regulatory solution for all medical devices to meet the requirement in Asia countries
More The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.
More Following a list new regulations and requirements released in March 2018, MDA has issued a new guidance document which specifies requirement on notification for importation and/or supply of medical devices intended solely for the purpose of demonstration for marketing or for the purpose of education.
More Based on a recently issued circular letter, No. 3 Year 2017 (Rev.1), MDA has reiterated the implementation and enforcement date for the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combinations Products, which will be strictly enforced in Malaysia starting July 1st, 2019.
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On 30th of November 2017, following recommendation from the Advisory Board, Thai FDA had announced four new checkpoints which regulate importation and exportation of medical devices. The new checkpoints are located in four different provinces as follows:
More The Thai Medical Device Control Division has amended the application form for medical device advertising following the Thai FDA announcement on 19 January 2018. It is appropriate to report complete and clear information to monitor the impact of disclosure.
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In light of the new Medical Device Rules 2017, CDSCO/CLA/SLA shall have updated information of laboratories involved in testing of medical device & in vitro diagnostics with respect to their laboratory reports and decision on performance evaluation of products made by stakeholder/regulator.
More The Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, Government of India has recently issued guidelines for implementation of Public Procurement Order No. 17 (PPO) in an aim to mandate procuring entities to make local suppliers as their priority purchase preference for medical devices,
More The Government of India, Ministry of Health and Family Welfare has released guidelines with respect to Grouping of Medical Devices for applicants who intend to apply for a license to import or manufacture medical devices for sale and distribution in India.
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