Beginner's Guide to Exporting. 4th Edition.
3 5 Beginner’s Guide To Exporting Sector Standards / Certifications Machinery & Equipment • European Conformity (CE) Marking • ISO • SIRIM • API Standard (American Petroleum Standard) – for machinery in oil and gas sector • NADCAP and European Standards (EN) - for aerospace engineering, defense and related industry • Technical Specification Standard (TS) – for automotive Pharmaceutical • Free Sales Certificate • Manufacturing License from National Pharmaceutical Control Bureau • Good Manufacturing Practice (GMP) • Good Distribution Practice (GDP) Medical Device Registration and Export Permit • The term “medical device” covers any product used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or handicap but excludes drugs. Please refer to Section 2 of Medical Device Act 2012 (Act 737) for complete definition of term “medical device”. • All medical device for export must be registered and apply for export permit. Application for registration and export permit shall be made to the Medical Device Authority, Ministry of Health Malaysia For more information please refer to : • Medical Device Act 2012 (Act 737) • Medical Device Authority Act 2012 (Act 738) • Medical Device Regulation 2012 ISO 13485:2016 • Medical devices, Quality management systems, Requirements for regulatory purposes. Certificate of Conformity (COC) Designed to ensure that specific products meet the requirements of the technical regulations and standards set by a regulatory authority in the importing country. Countries currently implementing PVOC (Pre-Verification of Conformity) Programme are Algeria, Burundi, Cameroon, Egypt, Ethiopia, Gabon, Ghana, India, Kenya, Kurdistan, Kuwait, Mongolia, Nigeria, Qatar, Saudi Arabia, Tanzania, Uganda. For more information, please contact SGS, Bureau Veritas, Intertek Group or China Certification and Inspection Company (CCIC). APPENDIX 1
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