NPI has experience working in several segments including: General Hospital, Medical Instrument, In Vitro Diagnostics, Dental, Wound Care, Ultrasound/Imaging, Aesthetic, Ophthalmic, & Endoscopy. NPI has a strong core competency in electro-mechanical applications (razor/razor blade "delivery systems") with a focus on non-invasive technologies.
The SFDA stands for (State Food and Drug Administration) It is the China equivalent of the FDA in the United States.
There are 3 medical device classes. Pricing may vary due to the complexity of the product or regulation changes. Additionally, pricing may depend on whether or not clinical trials are required.
| Device Classification |
Description | Est. |
|
|---|---|---|---|
| 1 |
|
6-9 months |
|
| 2 |
|
7-12 months |
|
| 3 |
|
1-2 years |
Not necessarily. In many cases device classifications in China may be different from the U.S. and CE. Determining the classification of the device using order No. 15 of SFDA guideline is typically the first step in the regulatory process.
If the product does not get market clearance from the country of origin, then it needs to go through a clinical trial. In general, most invasive products and IVD products will require clinical trials.
It depends. In many cases it can take a half a year, but for implantable products, it may require 1 year.
Please refer to the SFDA regulatory map on our website.
- Product registration is valid for 4 years
- Language barriers to communication
- Renewal application must be submitted 6 months before import license expires
- Sample testing may be repeated again
- Post-market quality and safety surveillance report is required
Yes, NPI has a strong relationship with one of the largest legal firms in China. The group is a leading full-service Chinese corporate and commercial firm with 9 offices around China. The group was established in 1998 and has more than 120 partners and approximately 620 PRC- licensed attorneys, many of whom are recognized as top practitioners in their respected fields of specialization, and a number of foreign counsel who "bridge the gap" between East and West. NPI also works with several of the most well respected legal firms in the United States.
Through our legal partners NPI provides the following services to help our clients successfully and safely enter the Chinese market.
- Intellectual Property Registration
- Patent Protection
- Freedom to Operate (FTO)
- Foreign Direct Investment (WOFE, JV Alliance Structures)
- Chinese 3rd Party Capital Attraction (NPI & Legal Group)
- Trade Contracts/Legal Document Review & Dispute Resolution
- Trademark protection
- FCPA (Foreign Corrupt Practices Act)
- Product Manufacturing (localization) contract & structure support services
Yes. NPI identifies the appropriate
channel partners and develops a customized distribution strategy to ensure a higher
probability of long-term success for our clients. In many cases NPI acts as our clients'
surrogate GM in China providing both strategic and tactical oversight over the entire
distribution network.
Yes. NPI has proven manufacturing and ISO13485 oversight experience in China.
The reimbursement system for medical devices in
China is somewhat complicated, especially with its tendering system for certain types of medical
devices. Reimbursement amounts can vary depending on which China province is involved. In
some cases reimbursement can differ between hospitals. Getting listed on the reimbursement
catalog is necessary to ensure the sales of your medical device in China. Reimbursement and
medical device pricing is regulated by the National Development and Reform Commission
(NDRC) and the Ministry of Health (MOH).
Please visit the China Manufacturing Frequently Asked Questions.