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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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MALAYSIA: Raminder Notice on the Complete Enforcement of Requirements for Registration of Medical Device - July 2018

MALAYSIA: Raminder Notice on the Complete Enforcement of Requirements for Registration of Medical Device - July 2018

  • 2020-02-13 06:23:56

MDA has released a Circular Letter at the end of May 2018 as a reminder notice on the complete enforcement of requirements for registration of medical device under Section 5 of Medical Device Act 2012 (Act 737), whereby no medical device can be allowed to be imported, exported or marketed in Malaysia unless it has been registered with MDA, according to this Act.

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MALAYSIA: Circular Letter No 3 Year 2018: Recognition and Listing of Institute or Laboratory Which is Capable to Carrying Out Clinical Evidence or Performance Evaluation for the purpose of Conformity Assessment - July 2018

MALAYSIA: Circular Letter No 3 Year 2018: Recognition and Listing of Institute or Laboratory Which is Capable to Carrying Out Clinical Evidence or Performance Evaluation for the purpose of Conformity Assessment - July 2018

  • 2020-02-13 06:21:59

Medical devices to be registered in Malaysia must first undergo conformity assessment with a Conformity Assessment Body, to demonstrate its conformity to the requirements of medical device law. In regards to this, currently there are conformity assessment service with good quality and also comparable to global assessments or test carried out by local laboratories.

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