This article is not meant to contain legal or accounting advice. DO NOT rely on this article for advice on filling in FORM 3602A. THERE MAY BE ERRORS. I am simply reporting my process for completing this form in November 2022. The FORM 3602A I refer to in this post are the most recent version as of the time of posting. The rules and forms might change in the future. Basically, don’t sue me please.
If you are a small Malaysian medical device manufacturer seeking to obtain a waiver on the FDA Medical Device User Fee, you might be interested in the CDRH’s Small Business Program. The Program determines whether your business is qualified as a “small business” or not – and small businesses are eligible for reduced fees for some CDRH submissions.
FORM 3602A is the application form used for foreign small businesses. In this post, I hope to share my experience completing the form in an open manner.
- First things first – I downloaded the form. I had to ensure the form I downloaded was the most recent version of the form by looking at the top right hand corner of the form.
- Next I filled in the details. In the most recent (as of the date of writing) FORM 3602A, there were detailed instructions on how to complete the form from page 3 onwards.
- The Organization ID number could be obtained by visiting the FDA User Fee Website. There is a process to this, so don’t expect it to be immediate. The information on the website is comprehensive, so I won’t repeat it here. In case you are wondering what a DUNS number is, speak to Dun & Bradstreet.
- To fill out Section 2, I had to check the foreign exchange rate page of the LHDN’s website (https://www.hasil.gov.my/en/international/foreign-exchange-rate/), and convert each month’s revenue based on the foreign exchange rate of that month (so no, you can’t just wing it and use a conservative rate like 1USD = 4MYR). The best way for me was to check our e-C filing and annual report for the revenue.
- Once I was done with step 4, I brought the completed form 3602A to the closest LHDN branch. The officer on duty had not seen the form before, and told me that they had to refer to HQ to ascertain how to fill in Section III.
- The LHDN compared my section II figures against our most recent tax filing. This could get confusing, but bear with the LHDN staff and remind them that gross receipts is not the same as income.
In sum, it’s not a “one-day-kao-tim” process. There were interactions with the FDA Userfees website, D&B (to get a DUNS number), and the LHDN. From start to finish, it took us a few weeks and several trips to the local LHDN branch (though in hindsight, 1-2 trips would have been enough, if it weren’t for my inexperience).
If you’re looking to fill in the form as well, don’t be an idiot like me and speak to your accountants early. Read the user fees and MDUFA websites (especially the FAQs).
All the best!
Last updated: 23 Nov 2022
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