Beginner’s Guide on Starting a Biomedical Business in Singapore

Starting a Biomedical Business in SingaporeAsia’s biomedical industry has made extraordinary advances in recent years. Singapore is one of the top regions with leading bio-clusters. Today, many top world pharmaceutical and medical technology companies have set up regional headquarters in Singapore. Singapore is also an attractive location to set up clinical trials research centers for multinational pharmaceutical and biotechnology companies. So, readers with interest to venture into starting a biomedical business here in Singapore. This is your golden chance! Here’s a quick guide to company registration in Singapore.

 

What Is a Biomedical Business?

At the growth of the biomedical sciences industry in Singapore, the biomedical sciences manufacturing sector surfaces as the fourth pillar of the manufacturing economy, resulting in the Singapore government laying down a strategic futuristic healthcare system. This has, in turn, created better jobs and skills, increasing productivity and catalyzing innovation which is a major benefit to those interested in starting a biomedical business. Major research institutes and biomedical giants, not forgetting the syndicate of local companies, make up Singapore’s biomedical terrain. Dealing in ground-breaking products from medical technology, biopharmaceuticals, and complementary health products, including supplements and traditional medicine.

 

How Do You Go Through the Business Registration Process?

Step 1 Is Deciding What to Name Your Company

Your company’s name should be something attractive, so it gives a good first impression to your investors and customers and should be something meaningful. If nothing comes to mind, relax your mind, and I’m sure that inspiration will come your way. Don’t forget to get your company name approved by the Accounting and Corporate Regulatory Authority (ACRA). You can do this via a simple online procedure. There are a few guidelines that you should abide by when choosing your company name.

  1. It cannot be identical to any existing business in Singapore
  2. It must not infringe on any trademarks
  3. It can’t be vulgar or obscene
  4. Any other company must not have reserved the name

If the company name follows ACRA’s rules, it usually takes less than an hour to get approval.

Step 2 Is Choosing a Resident Director

Next, you need to choose the resident director of your company. This is an essential part as it is a requirement in the Companies Act that every company in Singapore needs at least one resident director. Tip to find your perfect director, think of the qualities you think are necessary for the resident director of your company, then look for your perfect candidate. Your candidate should either be a Singapore Citizen, a Singaporean Permanent Resident or a person who has been issued an Entrepass, Employment pass or Dependent pass.

At the same time, you can also start identifying who are your shareholders for your biomedical business. It is a requirement to have a minimum of 1 with a maximum of 50 shareholders. Another tip for you, my lovely readers, shareholders are not limited to individual persons. It can be a person or another legal entity such as another company or even a trust. One benefit of starting a biomedical business in Singapore is that 100% local or foreign shareholding can be done. Also, new shares can be issued, or existing shares can be transferred at any time in accordance with the Constitution of the company.

Step 3 Is Getting Your Capital Ready

All businesses need capital, especially when starting a biomedical business which is important as you will be using this money to purchase assets and to maintain the business operations. This comes in two forms, called debt and equity. Equity usually means it does not involve a direct obligation to repay the funds. Instead, the equity investors receive an ownership position in the company, which generally takes the form of stock known as stock equity. Debt refers to loans and other types of credit that must be repaid in the future with interest. So, my dear readers, choose wisely.

Step 4 Is Engaging a Professional Firm

I know many of you will find the earlier steps rather difficult and tedious but don’t worry, my dear readers. Prepare all your paperwork beforehand to ensure a smooth process. You will need to submit the documents to the ACRA. Hire a corporate service provider in Singapore like 3E Accounting Singapore.

Step 5 Is Hiring a Company Secretary

Which is a requirement according to Singapore law, where all companies are required to appoint a company secretary within six months of its incorporation. Take note that a sole director or shareholder cannot act as the company secretary, and the company secretary must be a Singaporean resident.

After all these big steps, you can finally be the owner of your own biomedical business in Singapore. Congratulations!

 

Obtaining A License

When starting a biomedical business, you need to apply for a product license before releasing your products. If you intend to export your products, you will also need this license as a biomedical company in Singapore. Wondering where to get this license? You can obtain this license from the Health Sciences Authority in Singapore. Still, have queries in regards to licensing or incorporation of your business? Ask for a company incorporation service. There are quite a few of them in Singapore, and one of them is 3E Accounting.

Speaking of which, you first need to identify whether you are a manufacturer or an importer and wholesaler as the license you need are different.

If you are an importer or wholesaler, you need to identify what you are importing. For example, you can import or wholesale therapeutic products for clinical use, or you can import therapeutic products solely for supply to ships/aircraft, export, or non-clinical use, or even products for veterinary use or even products for clinical trials only. Responsible Person” (RP) must be named in the importer’s or wholesaler’s license. The licensee hires and appoints this individual to implement and maintain a quality management system that complies with the Good Distribution Practice (GDP) standard. Besides, if your company deals in any of the following, the RP in the importer’s or wholesaler’s license must be a registered pharmacist.

If you are a manufacturer, you need to submit certain documents to get your license, which is a lengthier application. You will also need to comply with the Good Manufacturing Practice (GMP) standard. This covers all manufacturers of therapeutic products, including assemblers. When HAS receives your license application, they will contact your company to arrange for a pre-approval audit. A pre-audit letter will be sent to you to inform you of the date of the GMP audit.

Your Site Master File (SMF) should be prepared in accordance with the Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) available from the PIC/S Publication website. The following topics need to be addressed in your SMF:

  1. General information
  2. Pharmaceutical quality system
  3. Personnel
  4. Premises and equipment
  5. Documentation
  6. Production
  7. Quality control
  8. Outsourced activities
  9. Complaints and product recall
  10. Self-inspection

If your biomedical business meets the GMP standard, a manufacturer’s license will be granted and provided to you ten working days after the audit closes.

Once you have your license, your company needs to comply with the routine audits to ensure that it remains in compliance. The frequency of routine audits will be determined by risk variables such as your company’s activities and your degree of compliance with regulatory standards. Unannounced audits are also a possibility.

To apply, you need to submit your application through PRISM. And another tip for my lovely readers, you need to have the following before you apply:

  1. CRIS company account
  2. CorpPass or HSA PIN

 

What Are the Necessary Documents?

For importer and wholesaler licenses, the documents you need are as follows. Please note all the following documents must be in English.

  1. Current layout plan for the premises, specifying the storage areas.
  2. Pharmacist Practising Certificate if the Responsible Person is a registered pharmacist.
  3. Authorization letter from the product registrant, if your products are not registered under your company (only applicable for importer’s license application).
  4. List of products to wholesale (only applicable for wholesaler’s license application).
  5. Good Distribution Practice (GDP) standard operating procedures.
  6. GDP records or recording templates.
  7. Store approval letter.
  8. Other supporting documents, if applicable.

These are the documents you need for a manufacturer’s license.

  1. Site Master File
  2. Certificate of Accreditation of the contract testing laboratory, if any.
  3. Letter of approval issued by the agency or institution that approves the use of the premises for the manufacturing and storage of therapeutic products, if applicable.
  4. Details of the products and dosage forms manufactured and/or assembled, including the name and strength, as well as product registration number, if applicable. Also, indicate if your company is acting as a contractor acceptor (i.e. manufactures partially or wholly for others) for these products.

Starting a Biomedical Business in Singapore

 

The process of starting a business in any industry can get complex. It may seem daunting, starting a biomedical business in Singapore, but our company formation specialists can assist you with the incorporation of your company. You may contact us should you require any assistance or services. We provide these services to ensure a smooth integration into the economy in Singapore.