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HONG KONG:  MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

HONG KONG: MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

  • 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

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QT ANALYSIS: Hong Kong Medical Devices Market and Registration Overview

QT ANALYSIS: Hong Kong Medical Devices Market and Registration Overview

  • 2021-01-19 02:59:53

Hong Kong boasts a wealthy and sophisticated medical device market. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a booming medical device market in Asia and how you shouldn’t miss out on the great business opportunities it offers.

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HONGKONG: Continuance of trial to accept marketing approval  obtained from the National Medical Products Administration for listing application of medical devices  under the Medical Device Administrative Control System (MDACS) - March, 2020

HONGKONG: Continuance of trial to accept marketing approval obtained from the National Medical Products Administration for listing application of medical devices under the Medical Device Administrative Control System (MDACS) - March, 2020

  • 2020-03-16 06:42:41

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices. 

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HONG KONG: In Vitro Diagnostic Medical Device Classification Program - November 2018

HONG KONG: In Vitro Diagnostic Medical Device Classification Program - November 2018

  • 2020-02-12 14:12:33

MDCO has created and developed a Web-based In Vitro Diagnostic Medical Device Classification Program, where previously only the classification program for General Medical Device was available. This is to facilitate the classification of the In Vitro Diagnostic Medical Device according to its risk level under the Medical Device Administrative Control System.

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 HONG KONG: New Guidance for Importer Listing in Hong Kong – July 2018

HONG KONG: New Guidance for Importer Listing in Hong Kong – July 2018

  • 2020-02-14 03:56:57

MDCO has revised guidance document related to Importer Listing in Hong Kong, that are GN-07 Guidance Notes for Listing of Importers of Medical Devices, COP-04 Code of Practice for Listed Importers of Medical Devices, and Application for Inclusion on the List of Importers/ Distributors (Form MD-IP+D). This new guidance will be fully implemented start from June 1st 2018.

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HONG KONG: CNDA (Formerly Known as CFDA) Now Recognizes Special Certificates Issued by MDCO – July 2018

HONG KONG: CNDA (Formerly Known as CFDA) Now Recognizes Special Certificates Issued by MDCO – July 2018

  • 2020-02-14 03:52:53

China National Drug Administration (CNDA) (formerly known as CFDA) has issued a new policy for Hong Kong medical device manufacturers to enter Mainland China market. CNDA can now accept Certificate of Listing and Certificate to CNDA as marketing approval and Quality Management System certificates which are the necessary documents for medical device registration in China.

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