China manufacturing frequently asked questions

1.What medical device segments does NPI have experience working in? What types of products/technology?

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.

2. What does SFDA stand for and what product categories are there?

The SFDA stands for (State Food and Drug Administration) It is the China equivalent of the FDA in the United States.

3. What are the current classifications of medical devices?, What is the cost? How long will it take to obtain product registration?

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.
Time Frame*

General control, safety and effectiveness can be ensured through routine administration.

6-9
months

Further control is required to ensure safety and effectiveness.

7-12
months

Implanted into the human body, or used for life support of substenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness

1-2 years

*Timing may increase depending on whether or not a current classification exists and whether clinical trials are required

4. Are product classifications in China the same as in the U.S.? If my device is a Class I in the U.S will it be considered Class I in China?

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.

5. When would you require clinical trials for Class II?

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.

6. What is the time range for a clinical trial?

It depends. In many cases it can take a half a year, but for implantable products, it may require 1 year.

7. What is the regulatory process? What steps are required to submit my device?

Please refer to the SFDA regulatory map on our website.

8. How often do I have to renew my registration?

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

9. Does NPI provide legal services?

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.

10. What legal & professional services do you provide?
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

11. Does NPI provide distribution management 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.

12. Can NPI provide a "local manufacturing solution" for my medical product?

Yes. NPI has proven manufacturing and ISO13485 oversight experience in China.

13. Is there medical reimbursement 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.