Hong Kong Medical Device and Pharmaceutical Regulations

Although Hong Kong is a Special Administrative Region of China, it does not follow the same medical device or pharmaceutical regulations as the mainland. The Medical Device Control Office (MDCO) and the Drug Office under Hong Kong’s Department of Health (DH) are responsible for regulating the country’s medical devices and pharmaceuticals, respectively. The MDCO is tasked with overseeing the Medical Device Administrative Control System (MDACS) and developing the regulatory framework for medical devices. The Drug Office handles the registration and import/export of drugs; the inspection and licensing of drug manufacturers, wholesalers, and retailers; and pharmacovigilance and risk management.

The Medical Device Administrative Control System (MDACS)

There are currently no comprehensive regulations governing the manufacture, importation, distribution, or sale of medical devices in Hong Kong. The MDCO was established with the express purpose of instituting regulations that comply with international standards, and the office has been working to establishing an official set of medical device regulations since 2004. To allow traders to become familiar with the future mandatory requirements, the MDCO released the Medical Device Administrative Control System (MDACS), which so far has implemented the voluntary listing of Class II, III, and IV medical devices and Class D in vitro diagnostics; the listing of local manufacturers, importers, and distributors; and a recognition scheme for conformity assessment bodies (CABs).

Medical devices in Hong Kong are categorized into four classes by risk level, which generally depends on the design and intended use of the device. Class I medical devices are considered low risk, Class II and III medical devices are considered medium risk, and Class IV medical devices are considered high risk.

The Pharmacy and Poisons Ordinance (Cap. 138)

In Hong Kong, Western (non-Chinese) medicines are regulated under the Pharmacy and Poisons Ordinance (Cap.138). Other relevant regulations include the Import and Export Ordinance (Cap.60), the Undesirable Medical Advertisements Ordinance (Cap. 231), the Antibiotics Ordinance (Cap. 137), and the Dangerous Drugs Ordinance (Cap. 134).

All pharmaceutical products are required to be registered with the Pharmacy and Poisons Board (PPB) before they can be sold in the country. In order to obtain registration approval, the applicant must submit information including the production formula, product specification, laboratory report, and manufacturer license to the PPB. After receiving approval, the PPB will issue the product a registration number, which must be printed on the medicine label.

Pharmaceutical products are grouped into three main categories based on the severity of the diseases they are intended to treat, as well as the magnitude of side effects they cause:

• Category 1 – “Prescription Drugs” used to treat serious diseases. Incorrect dosage or improper use could result in serious health damage. These medicines require a doctor’s prescription to be dispensed and sold in registered pharmacies under the direct supervision of registered pharmacists.
• Category 2 – “Drugs Under Supervised Sales”. Incorrect dosage or improper use could cause health risks. These medicines must be sold in registered pharmacies under the supervision of registered pharmacists, but do not require a doctor’s prescription.
• Category 3 – Drugs used to treat or alleviate minor illnesses, with few side effects. Incorrect dosage or improper use could still result in undesirable side effects. These medicines can be sold in pharmacies or stores without resident pharmacists.

All pharmaceutical manufacturers and importers are also required to obtain the proper licenses before they can commence operations. Manufacturers must comply with Hong Kong’s good manufacturing practice (GMP) standards. The Department of Health conducts regular audits to make sure that the licensees are in compliance with GMP and other regulatory requirements.

For more detailed information about registration requirements and the regulatory pathway for medical devices and pharmaceuticals in Hong Kong, please see Medical Device Registration in Hong Kong and Pharmaceutical and API Product Registration in Asia.

Hong Kong Medical Device and Pharmaceutical Regulatory Resources

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