A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

How New EU MDR Requirements Will Affect Registrations in Asia

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As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.

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Indonesia e-Catalogue Implementation Review, December 2022

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On April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.

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Indonesia Revamps eCatalogue Procurement System

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On February 11th and 14th, the Ministry of Health of the Republic of Indonesia implemented significant structural and procedural changes to the government procurement system known as e-Catalogue as it applies to medical devices (reference announcement KN.01.04/3/630/2022). Under the new rules, oversight of the e-Catalogue has been moved under the Ministry of Health and will not require negotiations.

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Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue

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On July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,

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Hong Kong to Pilot Prioritizing Some Listed Medical Devices

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Hong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.

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Good Distribution Practice Requirements in Indonesia

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In 2014, the Indonesian Ministry of Health introduced the Good Method of Distribution of Medical Devices (or CDAKB) in order to enforce good distribution practice requirements in the country.

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China’s NMPA Begins Issuing Registration Certificates Electronically

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On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.

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Expedited Market Access Now Available in Philippines

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On September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.

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Asia Actual is the Best Medical Device Consulting Company in Asia

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Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

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Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR

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Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products.

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