Brandwood Biomedical has been working in Taiwan for several years, including supporting a number of clients in navigating the regulations and post-market requirements. With an increasing population of 23.5 million and a Medical Device market of US $4.7 billion reported in 2016, it’s not surprising that companies are still very interested in entering this lucrative market. And with 13% of the population over 65 years, there is a growing need to have innovative technology introduced to market. It’s for this reason, Brandwood Biomedical is excited to announce its 5th office within the Asia Pacific region, and its 6th office globally.
With the Medical Device regulations being in place since 2015, the system is well established and managed.
There are 4 regulatory pre-requisites before you can apply for Taiwan FDA approval.
- Similar to many of the Asian markets, you must have your product approved in your country of origin. Remember your Country of Origin is the location of the legal manufacturer. If your product is manufactured in the USA, you will require an FDA approval;
- The manufacturer will need to define a predicate in Taiwan. This is the preferred approach in Taiwan as if there is no predicate – there is likely to be a longer process and additional clinical data/research information required. Be mindful that the predicate can be from a different manufacturer; equivalency similar to US 510k;
- The manufacturer will need a valid Good Manufacturing Practice (GMP) or QSD Certification;
- And have identified a Taiwan Sponsor. This, similar to other jurisdictions, is a critical step. You will be needing to work closely with the local sponsor both on the submission and for your post-market activities, so be sure they have the competency in the group to support your needs. Brandwood Biomedical can be your sponsor.
Once you’ve established the above, the first step is to prepare for the various steps of the applications. Remembering that there are two main stages. Firstly is the QSD application, which is then followed by the device application. Common documents for these stages are:
- Chinese and English Labelling Materials
- QSD Certificate
- Pre-Clinical & Quality Testing reports
- Product Information
- Clinical Evidence Report (for high-risk devices)
- Authorisation letter from the legal manufacturer to a local agent
- Sponsor Business License
- Some of the required documents are technical ie QC testing and pre-clinical. The remaining documents are generally administrative. A critical point to remember is that all submissions must be submitted by the local sponsor.
Stage 1: QSD Requirements
The QSD requirement allows the TFDA to review your necessary critical manufacturing steps as a way of ensuring compliance. For manufacturers that have a single manufacturing plant, the QSD is process is relatively straightforward. Where some manufacturers run into trouble is where they have multiple facilities responsible for various product lines. This is quite common for larger international manufacturers. If manufacturing steps for the product to be registered do occur across multiple sites, the QSD application should only be submitted for the QC final release site. If a legal manufacturer releases different products at different facility addresses, multiple QSD applications should be submitted for different production sites. The rule of thumb is one QSD for one manufacturing address. The manufacturer needs to be very diligent with ensuring the necessary documentation aligns with this approach as it will be identified during the QSD review or device application process.
The QSD Certificate must be in place prior to submitting your product registration and must remain valid throughout the entire product registration period. A lapsed QSD will also make your product registrations invalid.
The QSD Certificate is valid for 3 years once approved. It should be noted that it’s best to start your renewal process at the latest 6 months prior to expiration. There are currently 3 separate paths for obtaining your QSD approval.
1. Abridged Pathway for US manufacturers
a. Establishment Inspection Reports (EIRs) by FDA
b. Certificate to Foreign Government by FDA (CFG)
c.ISO 13485 certificate
2. Abridged pathway for EU manufacturers (including Switzerland & Lichtenstein)
a.Inspection Reports by European NBs
b.Free Sale Certificate
c.ISO 13485 certificate
3. Standard Pathway
a. ISO 13485 certificate
b.Full Quality manual, quality procedure & manufacturing flow chart
Across the 3, the timelines (target of 120 calendar days) and fees are the same. An “abridged” means less documentation is required (FDA EIR, ISO 13485, manufacturing inspection report) and typically you can expect fewer review questions. Also, note that TFDA only recognises the well-known 11 notified bodies. At this point, it’s unusual to see the TFDA do onsite inspections for overseas manufacturers, however, they may for domestic manufacturers.
*Note Class I devices (excluding sterile devices) are exempt from the QSD application.
Stage 2: Product Registration Process
The TFDA adopted the “catalogue-based” classification system similar to that which is used in the US FDA – where the classification is determined by the predicate device. Lower risk Class I devices simply need a declaration statement as part of the product registration. As you move to the higher risk products, the requirements differ. See images below for further clarity:
- Class II Products
Once approved, the TFDA registration is valid for a total of 5 years. Similar to that of the QSD Renewal, it is absolutely imperative that the preparation begins no later than 6 months prior to the expiration. This allows for the preparation of the manufacturer’s documentation, along with any potential questions received during the renewal process.
After approved, there are avenues for submitting Variations to the existing registration. These are dependent on whether the variation is a Technical Change or an Administrative change. These are listed below for reference.
1. Technical Variation
a. Change of intended purpose
b. Change of indication for use
c. Addition of model number or change of model specification
2. Administrative Variation
a. Change of product name
b. Change of manufacturer/sponsor information
c. Change of IFU/Labelling
d. Removal of model number
With such a well defined regulatory system and a growing demand for new technology, the growth for the Medtech industry is expected to continue growing.
If you’re considering entering the Taiwan market or would like to better understand the specific requirements for your products, please reach out to us for a free discussion on how we may support you.
Need help with regulatory approvals in Taiwan? Let our Mandarin speaking experts guide your way. Contact us for a free, no obligation discussion. Contact us for a free, no obligation discussion. Email email@example.com or call +61 2 9906 2984 (Sydney) or +…(Taiwan).