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

India Launches Scheme for Promotion of Medical Device Parks

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The scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).

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India’s CDSCO Releases Draft Notice for Suspending or Cancelling Import Licenses

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Prior to this draft notification, there was no explicit rule providing clarity about the cancellation or suspension regarding the import License in case of any violation of the conditions by the license holder while such provisions were included for a manufacturing license in the MDR 2017.

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Vietnam Requires Resubmission of Many Medical Device Registration Applications

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All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.

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India’s CDSCO Expected to Begin Enforcing Local BIS Standards

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On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

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Indonesia to Permit Some Class A Products to Register via Notification

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On January 10, 2022, Indonesia’s Ministry of Health released Indonesia Class A Notification Announcement 01.05500242022 establishing a new registration route for some low risk medical devices effective immediately.

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Vietnam’s MOH Holds Conference on Price Declaration

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The conference was held to provide clarity to the Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022.

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Thai FDA Fast Track Route for COVID Related Products to Stop

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The TFDA has announced that the Fast Track registration route for COVID related products will be discontinued from November 4th, 2022 onwards.

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Taiwan FDA Medical Device Advertising Requirements

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The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications

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Thai FDA Implements Initial Screening Step to Submission Process

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Beginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.

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India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries

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On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

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