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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: 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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 "Foreign Special Case Recognition Policy" Enables Foreign Medical Device Factory to Obtain Express Pass - June 2018

"Foreign Special Case Recognition Policy" Enables Foreign Medical Device Factory to Obtain Express Pass - June 2018

  • 2020-02-14 04:21:46

A research conducted by BMI Espicom showed that the scale of the global medical device market is expected to reach US$38.91 billion in 2019, of which Japan has the world’s second largest medical device market, second to United States. Global medical equipment manufacturers in addition to Europe and the United States well-known manufacturers (GE, Medtronic, Johnson & Johnson, etc.),

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