Best Drugs & Medical Devices Lawyers in Bang Khen

About Drugs & Medical Devices Law in Bang Khen, Thailand

Bang Khen is a district within Bangkok, and most legal rules that apply to drugs and medical devices here are set at the national level by the Ministry of Public Health and the Thai Food and Drug Administration. While national agencies issue the core regulations, local authorities in Bangkok help with facility inspections, business premises approvals, and enforcement. If you are manufacturing, importing, distributing, selling, or advertising medicinal products or medical devices in Bang Khen, you will work within a nationwide regulatory framework that emphasizes product registration, establishment licensing, quality standards, labeling, advertising controls, and post market surveillance.

Drugs are regulated primarily under the Drug Act B.E. 2510 and its amendments, the Psychotropic Substances Act, and the Narcotics Code. Medical devices are regulated under the Medical Device Act B.E. 2551 and subsequent amendments, which align Thailand with risk based classification used across ASEAN. Consumer protection, product liability, health data, and facility licensing laws also affect how products can be brought to market and monitored in Bang Khen.

This guide offers general information to help you orient yourself. It is not legal advice. Rules change frequently, so always confirm current requirements with a qualified Thai lawyer or regulatory specialist.

Why You May Need a Lawyer

Businesses and health professionals in Bang Khen often seek legal help to plan and obtain product registrations for drugs, medical devices, vaccines, biologics, combination products, and borderline products such as dietary supplements. A lawyer can assess whether your product is a drug, device, cosmetic, or food supplement and select the correct regulatory pathway, because the wrong classification leads to delays and penalties. Companies that manufacture, import, or distribute need establishment licenses, Good Manufacturing Practice or Good Distribution Practice compliance, and premises approvals. Legal counsel can prepare applications, communicate with Thai FDA, and coordinate inspections.

Thailand restricts advertising for many health products. Lawyers review marketing materials, digital content, influencer campaigns, and clinic promotions to ensure they meet pre approval and content standards. Pharmacies and clinics in Bang Khen must comply with professional practice rules, pharmacist in attendance requirements, prescription handling, and record keeping. A lawyer can help you set compliant standard operating procedures and train staff.

High risk areas include narcotics, psychotropics, cannabis and hemp, clinical trials, compassionate use, and named patient imports. Errors here can create criminal exposure. Post market duties such as adverse event reporting, recalls, field safety corrective actions, and complaint handling also carry legal risk. When inspections occur, or if you receive a warning letter or seizure notice, counsel can guide corrective actions and represent you in dealings with regulators. In disputes such as product liability claims, false advertising allegations, distributor termination, or parallel import conflicts, an experienced lawyer can protect your interests and manage litigation or settlement.

Local Laws Overview

Drugs in Thailand require product registration with Thai FDA before marketing. Establishments that manufacture, import, or sell drugs must hold the appropriate licenses. Thailand follows internationally recognized quality standards. Manufacturers must maintain Good Manufacturing Practice systems, and importers must source from GMP compliant sites. Prescription drugs may not be advertised to the general public. Over the counter advertising is tightly controlled and often requires prior approval. Sales of prescription drugs are restricted to licensed pharmacies with a pharmacist physically present during operating hours. Online sales of prescription drugs are prohibited, and online sales of nonprescription drugs are subject to strict conditions and enforcement.

Medical devices are regulated using a risk based framework aligned with ASEAN principles. Devices are categorized by risk, which determines the pathway. Lower risk devices are typically listed or notified, while higher risk devices require a full license before import or sale. Establishments that manufacture, import, or distribute devices must be licensed and maintain quality management appropriate to their activities. Labeling generally must be in Thai when devices are intended for lay users, and must include the registration or listing details, the Thai establishment information, and instructions for safe use. Advertising claims for devices must be truthful, substantiated, and often pre approved by Thai FDA, with additional restrictions for devices that could pose health risks if misused.

Narcotics and psychotropic substances are tightly controlled under the Narcotics Code and related laws. Special licenses, quotas, and record keeping are required to handle these substances, and penalties for violations are severe. Cannabis rules have been in flux. Policy has shifted and may continue to change, including the status of recreational use and controls on extracts and products. Businesses and clinics in Bang Khen should verify the latest ministerial notifications before cultivating, compounding, prescribing, marketing, or selling any cannabis related products.

Clinical trials involving investigational drugs generally require Thai FDA authorization and ethics committee approval. Import permits are needed for investigational products. For medical devices, clinical evaluations or investigations may be required depending on risk, novelty, and available evidence. Data privacy rules under the Personal Data Protection Act treat health data as sensitive personal data. Sponsors and sites in Bang Khen must implement appropriate consent and data protection safeguards for patients and subjects.

Product liability is governed by the Product Liability Act, which imposes strict liability on manufacturers and importers for defective products that cause damage. Consumer protection laws regulate unfair contract terms, misleading claims, and service standards for clinics and sellers. In Bangkok, local authorities coordinate inspections of pharmacies, clinics, and device distributors and may issue local approvals for premises. Coordination with Bangkok Metropolitan Administration departments is common for facility licensing, signage, and inspection scheduling.

Frequently Asked Questions

Do I need a license to import a medical device into Bang Khen

Yes. Importers must hold an establishment license for medical devices and must obtain the correct market authorization for each device based on its risk category. Low risk devices are usually listed or notified, while higher risk devices require a device license. Import without the proper authorization is illegal even if the device is approved in another country.

How are medical devices classified in Thailand

Thailand uses risk based classification aligned with ASEAN principles. Generally, Class 1 devices are lower risk and follow a listing route, Class 2 devices are notified, and higher risk devices require licensing. The required technical documentation, clinical evidence, and review time increase with the risk class. Borderline determinations can be complex, so early classification analysis is important.

What approvals are needed to market a new drug

You need a drug product registration from Thai FDA before marketing, an establishment license for manufacturing or import, and compliant labeling in Thai. Clinical data, quality data, and nonclinical data must support safety, efficacy, and quality. For imported drugs, the foreign manufacturing site must meet GMP standards acceptable to Thai FDA. Pricing and reimbursement are separate processes and do not replace registration.

Can I sell medicines online in Thailand

Online sale of prescription drugs is prohibited. Sale of nonprescription drugs online is tightly restricted and subject to enforcement. Any drug sale must comply with pharmacy licensing and pharmacist supervision rules. Many common online practices violate Thai law, so you should obtain legal advice before any online activity involving drugs.

What are the labeling requirements

Drug and device labels must be in Thai for products supplied to the general public and must include required particulars such as product name, active ingredients, strength, indications or intended use, directions, warnings, lot number, expiry date, and Thai registration or listing number with the name and address of the Thai license holder. Professional use products may have additional or different requirements. Claims on labels must match the approved indications or intended use.

Are advertisements for drugs and devices restricted

Yes. Direct to consumer advertising for prescription medicines is prohibited. Over the counter drug advertising and many device advertisements require prior approval and must follow strict content rules. Exaggerated claims, unsubstantiated efficacy, and testimonials that could mislead are not allowed. Digital marketing, influencer content, search ads, and clinic promotions are treated as advertisements and are within enforcement scope.

What are the penalties for noncompliance

Penalties range from warning letters and product seizures to fines, license suspension or revocation, and criminal charges. For controlled substances, penalties can be severe, including imprisonment. Selling unregistered products, false advertising, operating without a license, and dispensing prescription medicines without a pharmacist are common violations that attract enforcement.

Do I need approval to conduct a clinical trial in Bang Khen

Investigational drug studies generally require Thai FDA authorization and ethics approval. You will also need import permits for investigational products and must comply with Good Clinical Practice and data protection laws. Device clinical investigations may be needed depending on the risk and novelty of the device. Engage regulators early to confirm requirements.

What are the rules on cannabis and hemp products

Cannabis regulation has been evolving. Requirements for cultivation, extraction, medical use, and retail have changed and may change further. Licenses, product standards, advertising restrictions, and medical oversight can apply. Before any activity in Bang Khen, confirm the current status under Ministry of Public Health notifications and related laws.

How are product recalls and adverse events handled

Holders of drug or device authorizations must maintain systems to monitor safety, investigate complaints, and report serious adverse events to Thai FDA within the prescribed timelines. If a defect or risk is identified, you must execute recalls or field safety corrective actions, notify customers and regulators, and document the process. Having a written recall procedure and local contacts in Bangkok is essential.

Additional Resources

Thai Food and Drug Administration - Drug Control Division and Medical Device Control Division.

Ministry of Public Health.

Bangkok Metropolitan Administration - Department of Health.

Pharmacy Council of Thailand.

Medical Council of Thailand.

Consumer Protection Board.

Personal Data Protection Committee and Office for data protection guidance related to health data.

Standards and Metrology bodies that issue Thai industrial standards relevant to certain medical devices.

Next Steps

Clarify your product and business model. Determine whether your product is a drug, medical device, cosmetic, or food supplement, and whether you will manufacture, import, distribute, or retail in Bang Khen. Classification drives the regulatory pathway and timelines.

Engage a Thai regulatory lawyer or consultant. Ask for a scoping assessment that covers classification, establishment licensing, product registration strategy, labeling, advertising, and post market duties. For Bang Khen premises, confirm local facility requirements and inspection readiness.

Prepare documentation. Assemble company documents, quality certifications, technical files, clinical evidence, labeling drafts in Thai, and standard operating procedures for distribution, complaint handling, and recalls. For foreign manufacturers, secure current GMP certificates acceptable to Thai FDA.

Plan timelines and compliance. Registration and licensing can take months depending on risk and dossier quality. Build realistic launch plans, training for pharmacists or clinic staff, and monitoring systems for safety reporting.

Audit marketing and online activity. Review all promotional materials, websites, social media, and clinic signage for compliance. Obtain required pre approvals before any public use.

Monitor legal changes. Thailand periodically updates drug, device, and controlled substance rules. Assign responsibility to track new notifications and guidance, especially for cannabis policy and digital advertising practices.

If you receive an inspection notice, warning, or seizure, contact counsel immediately. Early, cooperative corrective actions often resolve issues faster and reduce risk.