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THAILAND: Ministry of Public Health Announce that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration 2020 – June, 2020

THAILAND: Ministry of Public Health Announce that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration 2020 – June, 2020

  • 2020-06-16 06:18:33

Despite the effect of COVID-19 outbreak, ThaiFDA continued to perform at its best for the Medical device regulation reform update. Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Thai FDA Announced that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration.

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INDONESIA: Provision of Customs and / or Excise Facilities as well as Taxation of Imported Goods for the Purpose of Handling COVID-19 – June, 2020

INDONESIA: Provision of Customs and / or Excise Facilities as well as Taxation of Imported Goods for the Purpose of Handling COVID-19 – June, 2020

  • 2020-06-16 05:58:49

Ministry of Finance Decree ( PMK-34/PMK.04/2020) stated that import of goods for the purposes of handling the COVID-19-related medical products are granted with customs and / or excise and taxation facilities. Applicant could apply the exemption through INSW website (http://www.insw.go.id/). This policy is started from 17 April 2020 until further date set by The National Disaster Mitigation Agency (BNPB).

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TAIWAN: Guidance for Pre-clinical Testing of Soft Contact Lenses – June, 2020

TAIWAN: Guidance for Pre-clinical Testing of Soft Contact Lenses – June, 2020

  • 2020-06-16 05:48:04

This is a specific pre-clinical testing guidance for products classified under Soft (hydrophilic) contact lens in Taiwan. The guidance provided a clear standard of (1) product description and specification, and (2) safety and performance data. The overall pre-clinical test data should include inspection specifications, methods, original records, and results.

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