HKMHDIA SME Development Fund Project
About HKMHDIA
Hong Kong Medical and Healthcare Device Industries Association is an association established to represent the interest of the medical & healthcare device industries in Hong Kong. It was incorporated in June 2003 as a company limited by guarantee under the laws of Hong Kong and was originally known as the Hong Kong Medical and Healthcare Device Manufacturing Association, as most of the members were manufacturers or contract manufacturers. The association was subsequently renamed as its current identity in November 2007 as our membership grows substantially and covers the entire value chain in the medical device industries including design house, components manufacturers, trades and companies which provide testing and certification services; whether they are local and multinational corporations.
Project Background
ISO13485 was updated from the version of ISO13485:2003 to ISO13485:2016 in March 2016. Compliance certificate for ISO13485:2003 will not be issued from March 2018 onwards and all ISO13485:2003 compliance certificate will be invalid from March 2019 onwards. Therefore, all companies holding ISO13485:2003 currently should take immediate actions to review and enhance their current QMS (from procedural documents to actual implementation) in order to accommodate the upcoming timeline for compulsory transition. Failure in catching up with the transition timeline may lose the certification on ISO13485, which may create risk in business survival in the medical device industry.
With the focus of ISO13485:2016 shifting to risk management and identification of any foreseeable problems throughout the medical device realization process, local medical device companies are required to perform a total change in mindset and implementation approach for their QMS upgrade. However, with different risk determination approach and understanding towards a specific medical device, different SMEs and CABs may have different evaluation on the risk associated with the medical device, so as to the process amendment for supplier management. Therefore, the discrepancy in interpretation between different parties has created an obstacle for local SMEs to effectively determine the most cost-effective upgrade methodology for complying with ISO13485:2016.
In view of the upcoming timeline for recertification, Hong Kong Medical & Healthcare Device Industries Association (HKMHDIA) has successfully applied an SME Development Fund from Trade and Industry Department to implement a project namely “To enhance the awareness and capability of local medical device industries in fulfilling the upcoming new requirements in newly-launched ISO13485:2016 Medical Device Quality Management System (QMS)” with Hong Kong Productivity Council (HKPC) being the project implementation agent.