Launch a Fredericton Medical Laboratory: Start Your 621511 Venture

Detailed Requirements

Here are the specific requirements for starting a medical laboratories in Fredericton:

• Medical Device Establishment License Required
  Facilities that import, distribute, or sell Class II, III, or IV medical devices must hold a Medical Device Establishment License from Health Canada and comply with quality system requirements. Medical Device Establishment License (MDEL) for importers, distributors. Medical Device License (MDL) for Class II-IV devices. Class I: exempt from MDL. ISO 13485 quality system. Device classification rules. Adverse event reporting. Contact Health Canada: 1-866-225-0709.
• Business Number (BN) Registration Required
  A 9-digit Business Number is required for most businesses operating in Canada. It is used to interact with the Canada Revenue Agency and other federal programs. Required for GST/HST, payroll, corporation income tax, and import/export accounts. Register FREE online through Business Registration Online (BRO) at canada.ca. Takes 15-30 minutes. As of November 3, 2025, online registration is MANDATORY for new BNs - phone registration no longer available. You'll need: business name, address, owner SIN, business type, and start date. BN (9-digit number) issued INSTANTLY online. Available 21 hours/day, 7 days/week (closed 3-6am ET for maintenance).
• Controlled Drugs and Substances Authorization Required
  Healthcare practitioners and facilities handling controlled substances (narcotics, benzodiazepines) must be authorized and licensed under federal regulations. Includes secure storage, record-keeping, and reporting requirements. Health Canada Controlled Drugs and Substances Act (CDSA) authorization. Dealer license for controlled substances. Pharmacies: provincial licensing. Hospitals: authorization. Narcotics: strict requirements. Monthly reporting. Security requirements. Contact Health Canada Controlled Substances: 1-866-358-0453.
• Business Licence Required
  General business licence required to operate a business in City of Fredericton. Apply to City of Fredericton for Business Licence: 1. Determine business category 2. Complete business licence application 3. Submit required documents (ID, lease, zoning confirmation) 4. Pay application and annual fees 5. Await approval and receive licence Contact City of Fredericton Business Licensing for specific requirements. Home-based businesses may have different requirements. Annual renewal required.
• New Brunswick Business Name Registration (SNB) Required
  Businesses in New Brunswick must register their business name with Service New Brunswick if operating under a name other than the owner's legal name. This applies to sole proprietorships, partnerships, and trade names. Registration provides legal recognition and is required for business operations and licensing. Registration can be completed online through SNB Online. Business name registrations for sole proprietorships and partnerships must be renewed every 5 years. To register a business name in New Brunswick: 1. Conduct name search ($13.80) 2. Complete registration through SNB Online 3. Pay $112 registration fee (includes Royal Gazette) 4. Receive certificate of business name 5. Renew every 5 years ($62) 6. Report any changes as required
• Partnership Registration Conditional
  Required for partnerships. Registration of partnerships. Register through Province of New Brunswick Corporate Registry or business services: 1. Conduct name search if applicable 2. Complete registration application 3. Submit required documents 4. Pay registration fees Contact Province of New Brunswick government services for specific requirements and fees. Annual reporting may be required.
• NB Corporation Registration Conditional
  Required if incorporating in New Brunswick. Incorporation under NB law. Register through Province of New Brunswick Corporate Registry or business services: 1. Conduct name search if applicable 2. Complete registration application 3. Submit required documents 4. Pay registration fees Contact Province of New Brunswick government services for specific requirements and fees. Annual reporting may be required.
• GST/HST Registration Conditional
  Required if annual taxable revenue exceeds $30,000 (small supplier threshold). Taxi/ride-share drivers must register regardless of revenue. Businesses with gross revenues over $30,000 in any single quarter or over four consecutive quarters must register for, collect, and remit GST/HST. Small suppliers (under $30,000) may register voluntarily. Register FREE online through Business Registration Online (BRO) when your revenue exceeds $30,000 in any 4 consecutive quarters (small supplier threshold). Takes 15-30 minutes. You MUST register within 29 days of exceeding threshold and start charging GST/HST immediately on the sale that made you exceed it. Need your BN (or get one simultaneously). As of Nov 3, 2025, online registration is mandatory. Voluntary registration available anytime for input tax credits.
• Payroll Deductions Registration Conditional
  Required if you pay salaries, wages, or other remuneration to employees. Must register before first pay period. Required if you have employees. You must withhold Canada Pension Plan (CPP), Employment Insurance (EI), and income tax from employee wages and remit to CRA. Register FREE online through Business Registration Online (BRO) when you hire your first employee. Takes 15-20 minutes. You'll need your Business Number (BN) or can get one simultaneously. Payroll account (RP) added to your BN instantly. Register BEFORE your first pay date. Required to deduct CPP, EI, and income tax from employee wages. For 2025: CPP rate 5.95%, EI employee rate $1.66/$100 insurable earnings.
• New Brunswick WorkSafeNB Employer Coverage Conditional
  Required if you have employees in New Brunswick. Employers in New Brunswick must register with WorkSafeNB (Workplace Health, Safety and Compensation Commission) and maintain coverage for workers. WorkSafeNB provides insurance coverage for workplace injuries and occupational diseases. Most employers are required to register, with limited exceptions. Registration must occur within 10 days of commencing business operations or hiring the first worker. Employers pay assessments based on their classification unit rate and assessable payroll. To register with WorkSafeNB: 1. Determine if you're in a mandatory industry with 3+ workers 2. Register with WorkSafeNB online or by phone 3. Report assessable payroll annually 4. Pay premiums based on industry rate ($1.18/100 avg 2024) 5. Maintain coverage and report workplace injuries 6. Experience rating affects rate (+80% to -40%)

Funding & Grants

Available funding programs that may apply to your medical laboratories:

• The HIPP provided up to $200,000 over 9 months for Stage 1 proof-of-concept, with Stage 2 covering up to 75% of eligible expenses over up to 3 years (minimum 25% applicant cost-share). Eligible applicants included Alberta post-secondary institutions, government entities, health delivery agents, and for-profit or not-for-profit organizations. The program …
• The Invest Ontario Fund (IOF) is administered by Invest Ontario, a provincial Crown corporation, to attract and retain strategic business investments in Ontario. The fund provides financial support of up to $4 million through a combination of grants and loans to companies undertaking significant investments in advanced manufacturing, life sciences, …
• The IDCCF addresses the impact of climate change on human health by funding projects that increase surveillance, research, and public awareness of climate-sensitive infectious diseases. Maximum $150,000 per year for projects up to 3 years in duration. Eligible applicants include not-for-profits, universities, Indigenous organizations, provincial/territorial/municipal governments. Federal departments and for-profit …
• SUAP provides contribution funding for a wide range of projects including substance use prevention, harm reduction, treatment, and recovery. Individual project awards have ranged from approximately $1.6 million to $6.3 million in recent announcements. Eligible recipients include not-for-profit health organizations, universities, Indigenous organizations, and other levels of government. For-profit organizations …
• CIHR Catalyst Grants are short-term seed grants (up to 1 year) designed as a first step toward larger, longer-term research projects. The Digital Health stream specifically targets early and mid-career researchers and Indigenous Health researchers working on digital health technologies. Application deadline: March 17, 2026. Total pool: $1,000,000 (approximately 10 …

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