MEDICAL DEVICE REGULATION IN CHINA
Medical devices are regulated by the National Medical Products Administration (NMPA), formally China Food & Drug Administration (CFDA) whose objective is to strengthen the supervision and administration of medical devices, ensuring their safety and effectiveness, protecting human health, and life safety.
The regulatory processes and evaluations by NMPA are challenging and having a consultant that can communicate well with the NMPA and the clinical trial support team will definitely help speed up the approval process.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN CHINA
Medical devices are classified into 3 categories namely class I, II, III (I being the lowest risk and III being the highest risk).
There will be communication with the relevant Testing Laboratory in seeking on the product type testing to be conducted or exempted based on equivalency of existing testing done by the manufacturer.
Apart from the submission of required documentation, some product category may also require a local clinical trial to be conducted and approved by the NMPA before the medical device product gets approval in China.
The ARQon local team in China will assist in the product registration and technical requirement documentation preparation. This also includes any clinical trial if required, the planning, approval, and conduct of the trial in China.
INNOVATION DEVICE PATHWAY
The NMPA has implemented the Innovation Pathway to encourage innovations of the medical device industry. It provides supported application process for fast regulatory clearance on qualified medical devices.
In order to qualify for the innovation pathway program, manufacturers must have solid traceable research data on Class II/Class III medical devices and valid Chinese Patent. This application must be submitted to NMPA within 5 years of patent publication, and its registration submission must be received within 5 years of NMPA'S confirmation of approval for this registration route.
Applicant qualify identification
The summary documents of research and development process and result
Technical document for product the intended use the working principle / mechanism of action the main technical specification and the basis; main raw material; main manufacture process chart, and the testing method of main technical specification
the identification document for product innovation the IP report A summary of academic papers, monographs, and documents published in the core journals that fully demonstrate the clinical value of the product. The analysis and comparison of similar products (if any) The innovation parts and the clinical value of the product
The safety and risk management report of product
The operation manual of product (change be sample)
For foreign applicant, there should be an Authorised Representative (AR) in China. The letter of commitment The letter of authorization The qualify identification documents of AR
The statement of authenticity
ASEAN / Asia REP
Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance.
Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative.
ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally.
Whether you are a local or foreign manufacturer, ARQon can assist to:
Be your local representative in the country.
Submit product registrations for all product classifications.
Set up the QMS & technical file for ISO13485, GDP and CE
Hold product license in the country.
Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
Appoint multiple importers and distributors.