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.
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.
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 |
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