Page 86 - OHKF_Biotech_EN

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inspection and allow enterprises on the “White List” to import
Policy recommendations for Central Ministries and Departments
Recommendation 7.2 Easing restrictions on
the import of bio-materials and medical devices bio-materials. The “White List” should comprise biomedical
enterprises in the Loop which conduct sound safety and risk
On the other hand, the import flow for bio-materials such as management of biologicals, with no precedence of high-risk
biologicals, biological samples and specimen is complicated and incidents. The Central authorities concerned can also authorise
inefficient; it also takes considerable time to review and approve the use of unregistered imported medical devices for R&D and
the importation of medical devices. Therefore, we recommend testing purposes by Loop-based biomedical enterprises and
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that the competent Central authorities allow Shenzhen Customs specific healthcare organisations in Shenzhen.
and market regulators to further improve the inspection and
quarantine procedures for importing bio-materials, expedite

86 For example, the best period for testing of Specific Pathogen-free (SPF) mice is 4 to 6 weeks after they are born. Under the prevalent mechanism, SPF mice are to be quarantined for 30 days
upon arrival; Foreign commercial genome sequencing usually requires results within 10–15 days but under the prevalent mechanism, the customs clearance of imported DNA/RNA of animal
and plant for genetic test usually takes around two weeks.
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