HOW TO OBTAIN MEDICAL DEVICE APPROVAL IN HONG KONG
Regulations
Currently, there are no specific legislative requirements for the importation and sales of medical devices in Hong Kong. However, in preparation for future legislation the Medical Device Control Office (MDCO) and the Medical Device Administrative Control System (MDACS) have been set up by the Hong Kong Department of Health.
MDACS currently includes an adverse incident reporting system and listing of local manufacturers and importers. More recently, the MDCO has established a recognition scheme for Conformity Assessment Bodies (CAB) to allow assessment and voluntary listing of Class II, III and IV (highest risk) medical devices. Listing can be a requirement of tenders for government contracts.
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Scope and Classification of Devices
The MDACS covers general medical devices, active implantable medical devices and in-vitro diagnostic (IVD) medical devices. Medical devices are classified according to the risk level associated with their intended use. All medical devices are classified into Class I, II, III or IV with one set of rules for medical devices and one set of rules for IVDs. The rules for medical devices are similar but not identical to the rules in Annex IX of EC Directive 93/42/EEC.
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Technical Documentation
All manufacturers/LRP are responsible for technical documentation demonstrating that the device conforms to the Essential Principles of Safety and Performance of Medical Devices in the MDACS. Both the statutory control and administrative control system were largely based on the recommendations of GHTF. ISO or international product standards are not usually mandatory but manufacturers are advised to adopt where possible recognized international standards. A European technical file with the addition of local labeling will cover most technical documentation requirements.
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Quality Systems
ISO 13485:2003 is used as the basis for the quality system of local manufacturers and overseas manufacturers.
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Local Distributors, Licenses and Registration
It is not a legal requirement to have a registered distributor or importer in Hong Kong but MDACS recommended that local manufacturers, LRP/overseas manufacturers, importers and products undergo voluntary MDACS listing. Devices can only be MDACS listed through a Local Responsible Person (LRP).
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Future Developments
Voluntary listing of IVD Medical Devices is likely in 2009/10. Legislation to make the assessment and listing of devices mandatory is expected in 2009/10 starting with higher risk devices.
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SGS Certification
SGS Hong Kong is approved by MDCO as one of a very few recognized conformity assessment bodies. SGS can offer conformity assessment certificates through the global SGS network of auditors and assessors to allow manufacturers and devices to be listed by the MDCO. Voluntary listing is highly recommended for manufacturers wanting to enter the Hong Kong market in a significant way and will pre-empt the mandatory listing scheme.
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SGS Training
SGS offers in house and public training on the Listing of Medical Devices in Hong Kong and the changes needed to the quality system to ensure compliance. Gap analysis audits can also be undertaken.
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Contact SGS
Advice on Medical Device Administrative Control System is available from SGS.
This summary should not be taken as a definitive description of the requirements as regulations and interpretations do change and this is intended to be an outline only. Manufacturers must verify the requirements that apply to them before proceeding.
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