Sole Distributorship Policy for Medical Devices & Household Healthcare Products in Indonesia

The Ministry of Health, Indonesia has a sole distributorship policy in place, which means that only one distributor can register any particular product brand or model in a certain period. It is important for the global community to acknowledge the sole distributorship policy for medical device and household healthcare product distribution before introducing their products into Indonesia.

The Ministry of Health of Indonesia regulates product registration and distribution processes for both medical devices and household healthcare products nation-wide. Only local companies with a valid distributor license issued by the Ministry of Health can act as the registrant for such products. The Ministry also has a sole distributorship policy in place, which means that only one distributor can register any particular product brand or model in a certain period. During the product approval process, the manufacturer or principal will be listed along with its authorized distributor/current registration holder. The authorized distributor/current registration holder is the only company eligible to import the products. Other companies are not able to import the products from the manufacturer or principal, on the registration holder’s behalf. It is important for the global community to acknowledge the sole distributorship policy for medical device and household healthcare product distribution before introducing their products into Indonesia.

2018-05-01T17:49:02+08:00 April 27th, 2018|News & Events|

The trade of Medical Devices in Vietnam

The trade of medical devices is a complicated process under Vietnam law. A company looking to trade in medical devices must satisfy several conditions.

Under Vietnam law the trade of medical devices is considered a conditional business and a company must satisfy several conditions: (more…)

2018-10-24T14:42:42+08:00 April 27th, 2018|News & Events|

Malaysia: Implementation and Enforcement of OEM Licensing and Product Registration Requirements

The Medical Device Authority in Malaysia recently published Circular Letter No.1, 2018 to address the licensing and medical device registration requirements for Original Equipment Manufacturers (OEM). Currently, OEMs are not regulated under the Medical Devices Act (Act 737) because they do not fit the definition of an establishment that acts as the manufacturer or authorized representative of a product; thus, they are not subject to medical device registration and establishment license requirements.

The Medical Device Authority, Malaysia, recently released Circular Letter No.1, 2018 to address the licensing and medical device registration for Original Equipment Manufacturers (OEM). Based on the Medical Device Act (Act 737), Section 15 (1), no establishment shall import, export or place in the market any registered medical device unless it holds an establishment license under this Act. Section 5 (1) also states that no medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act.

However, OEMs are not regulated under the Medical Devices Act (Act 737) because they do not fit the definition of establishments that act as the manufacturer or authorized representative of a product; thus, they are not subject to medical device registration and establishment license requirements. The Medical Device Authority acknowledged that an appropriate policy needed to be developed to enable OEMs to obtain a license and register products so that they can apply for a Certificate of Free Sale (CFS) to market their products globally.

Below is the policy decision regarding the implementation and enforcement of OEM licensing and product registration:

(a) Local manufacturer that perform activities as an OEM

  • Licensed as a manufacturer
  • Register the medical devices under its own brand as the Manufacturer, and
  • A declaration that the listed brand is the same as the registered medical device brand (in terms of manufacturing processes, specifications etc.)

(b) OEM for non-owned brands

  • Licensed as an authorized representative (AR)
  • Product registration:
  1. Registration using a brand name
  2. Registration is exempt from the conformity assessment body (CAB) requirements based on the MDA Circular Letter No.1/2017 registration requirements and exempt from labelling requirements for export-only medical devices

2018-04-30T09:47:53+08:00 April 27th, 2018|News & Events|

Singapore: Proposed Amendments to Health Product (Medical Device) Regulations

A series of proposed changes to the Health Product (Medical Device) Regulations 2010 have been announced by the Health Sciences Authority (HSA), Singapore. The proposed amendments intend to further improve the regulatory framework to facilitate access and innovation while safeguarding consumer health and safety.

The Health Sciences Authority, Singapore has proposed the following key amendments to the Health Product (Medical Device) Regulations 2010:

  • To facilitate faster access to lower risk medical devices:
    • Class A (low risk) medical devices – Product registration for all Class A will no longer be required. The requirement for information on a dealer’s license and a listing of Class A devices to be made available on a Public Online Database will still be applicable
    • Class B (low-moderate risk) medical devices – Class B medical devices with no safety issues globally and either approval from two independent reference regulatory agencies or approval from one reference regulatory agency plus 3 years of marketing history will be eligible for immediate market access
  • Standalone mobile medical applications with prior approval from at least one reference regulatory agency and no safety issues globally at the point of submission will be eligible for immediate market access
  • A licensed manufacturer will no longer require an Importer’s Licence for the purpose of manufacturing its own products
  • Currently, an application to the Health Sciences Authority has to be made for any changes concerning registered medical devices. Within the proposed amendments, non-significant changes (such as changes to the colour and the font size of device labels with no changes to  the content) will be able to be implemented by the company without needing to seek prior approval from the Health Sciences Authority
  • The amendments will provide clarification on the scope of regulatory controls, including the scope of telehealth devices that are regulated as medical devices
  • To safeguard consumer health and safety, changes to the requirements around “Trained user only” medical devices are also being proposed

2018-05-01T17:43:10+08:00 April 27th, 2018|News & Events|