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Hong Kong (Hong Kong - Medical Devices Control Office)

Manufacturers supplying medical devices to Hong Kong must ensure that their products meet the criteria of the Hong Kong Medical Devices Administrative Control System (MDACS), which is the responsibility of the Health Department executive agency called the Hong Kong Medical Devices Control Office.

Hong Kong medical devices certification is different to the schemes operated in many other countries and not currently a legal requirement, but will be replaced in the future with mandatory legislation. To bring your products to market, you can apply for assessment and voluntary listing. Indeed, this is recommended for companies with significant medical device exports to Hong Kong, or that wish to apply for government contracts. To ensure your successful entry to this market, contact SGS’s experienced medical device auditors for advice and assessment at the earliest opportunity.

SGS is a Hong Kong Medical Devices Control Office recognized Conformity Assessment Body and can undertake audits and technical documentation reviews of medical devices your organization manufactures or sells to the Hong Kong market. This scheme has already been extended to include in vitro diagnostic (IVD) devices and it is expected that will become mandatory in due course. Voluntary assessment now will prepare your organization for this development.

Our market leading services and global experience makes SGS your ideal certification partner for Hong Kong medical devices certification to allow you to sell your medical devices more easily in the growing market of Hong Kong. The right medical device certification at the right time is the key to winning new contracts, launching new products and entering new markets.

Meet the criteria of the Hong Kong Medical Devices Administrative Control System (MDACS) with audits and technical reviews from SGS.

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