The long road to FDA clearance

The holy grail for medical devices in to clear US FDA.  Perfint healthcare and Forus healthcare are working on the process on getting the clearance to expand into the US market. Both of them are at different stages of the clearance process.

Both the companies are working on the 510(k) route. It is based on medical devices similar to yours that have already received 510(k) clearance from the FDA, called “Predicate Devices. The 510(k) process applies to most Class II medical devices sold in the US and a small number of Class I and Class III devices as well.

The Emergo Group performed an analysis of publicly available FDA 510(k) data pulled from the FDA website.

• The analysis has shown that 95-97% of all 510(k) applications cleared by the FDA occur within one year of initial submission date.
• The number of 510(k) submissions submitted in 2011 which cleared within 3 months increased to 42% from 40% and the average number of days decreased to 138 days.

The average time for approval for various devices is as follows.

One important factor to keep in mind is that the FDA does not "approve" medical devices; they "clear" them for sale in the US. One could have a product that has been sold across the world, with doctors using them regularly, but for the product to be sold in the US it has to be cleared first by the US FDA. Given the size of the US market and their focus on reducing the overall cost of healthcare, it is an opportunity that is very difficult to ignore dispite the pain.





 

Regulatory approvals for Med-Devcies across the world

I was at the Perfint healthcare labs yesterday. I am extremely proud and amazed at the progress the company has made since the first time I met Nandu and team in 2007. What I saw there was cutting edge technology in interventional oncology. Technology that can re-create 3D and volumetric data of the anatomy around soft tissues. Th platform can revolutionize the way ablation planing can be done by radiologists using either CT or the Ultrasound. To my simplistic mind what I saw was like ablation for dummies...
The company has had its share of challenges. There are not many examples of high end technology being built out of India that too in medical devices. Given the nature of the domain, various countries across the world have certifications, registrations and clearances that are required before the product can be introduced.
Following is the list of approvals that are required in some of the countries. This will be useful if you are looking to expand into these countries. I have also added the approximate cycle time that will be required for approval.

Country registration details
Sno	Countries	Technical Documentation- Preparation Duration	Approval cycle time	Remarks
Import license /Voluntary registration /Notification
1	Malaysia	1 week	1 month	Voluntary registration- Allowed to sell prior to registration
2	Philippines	1 week	1 month	Import license issue needed
3	HK	1 week	1 week	Voluntary registration- Allowed to sell prior to registration
4	UAE	NA	NA	Import formalities
5	Kuwait	1 week	1 Week	Import formalities - Al perfirn product have been included in the notification
6	India	NA	NA	Ready
7	Vietnam	1-2 weeks		Import license needed
8	Thailand	2-3 weeks		Import license and thai FDA registration needed
	New Zealand	1 week	1 week	Notification to NZ WAND
9	Chile	NA	NA	Ready
IEC/EMC/FQC Test certificate required
10	Indonesia	1 week	3- 4 months	Ministry of health registration needed
11	Colombia	4-8 weeks (Translation involved)	3-4 Months after submission	INVIMA registration needed
12	Canada	1 week	2-4 weeks after submission	HC approval needed
Only CE Certificate required- Allowed to sell
13	Netherlands	CE TCF creation		CE mandatory
14	Sweden	TCF creation		CE mandatory
15	S.A	1 Week	1-2 weeks	CE mandatory +41 BM form to be filled
16	Jordan	1 week	1-3 weeks	CE mandatory
17	Germany	CE tcf creation		CE Mnadatory
18	Poland			CE mandatory
19	Belgium	CE tcf creation		CE mandatory
20	Spain	1 month Translation Needed		CE mandatory
21	Portugal	1 month Translation needed		CE mandatory
22	Italy	1 month (Tranlslation involved)	1 week after submission	CE +NSIS registration needed
23	Turkey	1-2 months (Tranlslation involved)		CE mandatory. Can export. (Additional product registration required)+ Bar code
CE/FDA+TCF docs+Approval time
24	Russia	around 8 weeks (Translation involved)	6 months after submission	CE+Notarisation needed+Registration needed
25	Saudi	2 days	One month from CE	CE dependent.Other documents ready+Saudi fda registration needed
26	Australia	2-3 days	Time cannot be predicted	TGA registration needed
27	Israel	1-2 weeks	4 months after submission	Ministry of Health submission needed
28	Mexico	5-8 weeks (Translation involved)	3-4 Months after submission	Expedited route of HC approval COFEPRIS registration needed
29	Singapore	4 weeks	6 Months after submission	HAS registration needed
30	Argentina	5-8 weeks (Translation involved)	6 Months after submission	ANMAT registration needed
FDA
31	US	3 months +Usbaility study	120 days	510K clearance needed
CE Certificate+TCF+ additional testing required
32	Brazil	2-3 months (Testing, Translation involved)	3-4 months after submission	INMETRO Certification+ANVISA needed
33	China	12 months (Testing, Transltaion involved)	3 months	Type testing in china+SFDA submission
34	Korea	2-3 months (Translation involved)	25 working days after submission	Type testing in Korea+KFDA TCF submission+Korean GMP certification process +CB EMC and safet certification waives korea testing
35	Japan	2-3 months (Translation involved)	1 year	No additonal testing+Documentation+Foreign manufacturer accreditation needed
36	Taiwan	4 months	6 months after submission	QSD application and Product certification

The journey to becoming a global med-device from India is far from over, but I am very excited to be part of this journey with Nandu and team.