Objectives of the Presentation
Why Should you Attend
- Determine device classification
- Determine if clinical trials will be needed for your device
- Ascertain the best route to CFDA approval in China
- Development of a Product Registration Standard
- Prepare final submissions
- Handle incident reporting, CFDA inspections and device registration renewals
- What are the document requirements for registration for each regulatory classification in China?
- Is local testing (type testing/sample testing) required for CFDA registration?
- Is approval in the Country of Origin required for registration in China?
- Determine the classification of your device by referencing Health Sciences Authority's GN-13: Guidance on the Risk Classification of General Medical Devices or GN-14: Guidance on the Risk Classification of In-Vitro Diagnostic Medical Devices
- Preparing medical device submission documents for HSA
- Properly classify your device to ensure a smooth registration process for TFDA
- Class II and III devices must have home country approval in place prior to Taiwanese registration
- Know the registration, labeling and language requirements and general expectations for each country
- Medical Device Control Office (MDCO) oversees medical devices in Hong Kong, but no specific regulation is currently in place regarding importation, distribution or sale of devices
- Compliance guidelines in Hong Kong, contained in the Medical Device Administrative Control System (MDACS), are based on Global Harmonization Task Force (GHTF) guidelines
- Take the necessary steps to minimize additional documentation requests from the approval body and other delays: Gap Assessment and Regulatory Roadmap
Attend this one hour webinar to understand in depth about Medical Device Registration and Approval Process for the Pacific Rim (including China, Singapore, Taiwan and Hong Kong). The China (CFDA) medical device approval process will be explained step-by-step. Securing regulatory approval to market your medical device in the small but lucrative Singaporean market means dealing with the Health Sciences Authority (HSA), the agency responsible for overseeing medical device registration in Singapore. Classification of devices in Singapore is based on a four-tier system (Class A, B, C and D), with Class A covering lowest-risk products and Class D covering highest-risk products. Before medical device manufacturers can legally sell their products in Singapore, they must comply with medical device regulations set forth by Singapore's Health Sciences Authority (HSA). Marketing your device in Taiwan requires approval from the Department of Health's Taiwan Food and Drug Administration (TFDA). In addition, quality system certification is also required prior to market authorization.
Many medical device market regulators around the world require foreign manufacturers to provide a Certificate of Free Sale (CFS) showing that their products are approved for sale in Europe. In these markets, your CFS must be presented to authorities as part of your registration process. Hong Kong is a Special Administrative Region of China but has its own legal and regulatory system. Although no mandatory regulations are currently in place for importation, distribution or sale of medical devices in Hong Kong, new rules are anticipated. To register your device with MDCO, you must first determine your product's classification—as in other markets, Hong Kong uses a four-tier classification system (Class I-IV) based on risk. This is important because currently only Class II, III and IV medical devices can be voluntarily listed on MDACS. Class I devices cannot be registered.
Who can Benefit
This webinar will provide valuable assistance and guidance to medical device and IVD companies involved in any aspect of the product registration and approval process in these countries. Employees and personnel who will benefit include:
- All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the registration and approval process
- Regulatory Affairs/RA Specialists
- Clinical Affairs
- Project Leaders
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Engineering/Technical Services/Operations